364 Medical Devices jobs in Bahrain

Regional Sales Director (Medical Devices)

67890 Northern, Northern WhatJobs

Posted 9 days ago

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Job Description

full-time
Our client, a global leader in the medical device industry, is seeking a strategic and results-driven Regional Sales Director to oversee their operations in **Shakhura, Northern, BH**. This hybrid role requires a dynamic leader capable of managing a sales team, exceeding revenue targets, and fostering strong relationships with healthcare providers and distributors. The ideal candidate will possess a deep understanding of the medical device market, exceptional sales leadership experience, and a proven ability to drive growth in complex healthcare environments.

Responsibilities include developing and executing regional sales strategies, setting performance goals for the sales team, and ensuring consistent achievement of quotas. You will be responsible for recruiting, training, coaching, and motivating sales representatives to reach their full potential. Building and maintaining strong relationships with key opinion leaders, hospital administrators, and procurement departments will be paramount. Market analysis, competitor intelligence gathering, and strategic account planning will be critical components of this role. You will also collaborate closely with marketing, product management, and clinical support teams to ensure a cohesive go-to-market strategy. Accurate sales forecasting, budget management, and comprehensive reporting to senior leadership are essential. The ability to navigate complex healthcare regulations and reimbursement landscapes is a significant advantage. This position demands strong analytical skills, strategic vision, and a passion for improving patient care through innovative medical technologies. You will be a key driver of our client's success in the region.

Qualifications:
  • Bachelor's degree in Business, Marketing, or a related healthcare field; MBA preferred.
  • 10+ years of progressive experience in medical device sales, with a minimum of 5 years in sales management or leadership.
  • Proven track record of exceeding sales targets in a competitive market.
  • Strong understanding of the healthcare ecosystem, including hospitals, clinics, and distributor networks.
  • Excellent leadership, communication, negotiation, and strategic planning skills.
  • Experience in market analysis and competitor benchmarking.
  • Ability to work effectively in a hybrid setting, requiring both remote work and on-site presence for team leadership and client engagement.
  • Familiarity with relevant medical device regulations and compliance standards.
  • Strong network within the healthcare sector is a significant asset.
This opportunity is located in **Shakhura, Northern, BH**, offering a stimulating leadership role within the vital medical technology sector.
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Senior Quality Assurance Manager - Medical Devices

511 Manama, Capital BHD140000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client is seeking a highly experienced and meticulous Senior Quality Assurance Manager to lead their Quality Management System (QMS) for medical device development and manufacturing. This critical role is fully remote, enabling you to leverage your expertise in regulatory compliance and quality excellence from anywhere. You will be responsible for developing, implementing, and maintaining robust quality assurance processes to ensure compliance with international standards such as ISO 13485 and FDA regulations (21 CFR Part 820). The ideal candidate possesses a deep understanding of the medical device industry, strong leadership capabilities, and a proven track record in driving quality initiatives and continuous improvement.

Key Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with relevant regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
  • Oversee all aspects of QA operations, including document control, change control, CAPA, audits, and risk management.
  • Lead internal and external audits, ensuring regulatory compliance and identifying areas for improvement.
  • Manage the complaint handling and adverse event reporting processes.
  • Develop and execute validation and verification protocols for software and hardware components.
  • Collaborate with R&D, Engineering, Manufacturing, and Regulatory Affairs teams to ensure quality is integrated throughout the product lifecycle.
  • Establish quality metrics and key performance indicators (KPIs), monitoring trends and implementing corrective actions.
  • Provide training and guidance to personnel on QMS requirements and quality best practices.
  • Lead continuous improvement initiatives to enhance product quality and process efficiency.
  • Review and approve product release documentation.
  • Manage supplier quality and conduct supplier audits.
  • Represent the company during regulatory inspections.
  • Effectively manage and mentor a remote QA team, fostering a culture of quality excellence.

Qualifications:
  • Bachelor's degree in Engineering, Science, or a related technical field. A Master's degree is preferred.
  • Minimum of 8 years of progressive experience in Quality Assurance within the medical device industry.
  • Extensive knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
  • Proven experience in developing and maintaining a comprehensive QMS.
  • Strong understanding of product development lifecycle for medical devices.
  • Experience with risk management (ISO 14971) and CAPA processes.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Demonstrated leadership and team management abilities, particularly in a remote setting.
  • Exceptional communication, interpersonal, and documentation skills.
  • Proficiency in quality management software and tools.
  • Ability to work independently and manage multiple priorities in a fast-paced environment.
  • Proficiency in English; knowledge of other languages is a plus.
This role is essential for ensuring the safety and efficacy of our medical devices and offers a significant opportunity to shape quality culture remotely.
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Senior Quality Assurance Engineer - Medical Devices

5501 Northern, Northern BHD125000 Annually WhatJobs

Posted 13 days ago

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Job Description

full-time
Our client, a leading innovator in the medical device manufacturing sector, is seeking a highly experienced Senior Quality Assurance Engineer. This fully remote role is crucial for ensuring the highest standards of quality and compliance in the design, development, and production of our cutting-edge medical devices. You will be responsible for developing and implementing comprehensive quality assurance strategies, conducting rigorous testing, and ensuring adherence to stringent regulatory requirements (e.g., FDA, ISO 13485). The ideal candidate possesses a deep understanding of quality management systems in regulated industries, excellent analytical skills, and a meticulous approach to detail. You will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to uphold product integrity and patient safety.

Key Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) in accordance with relevant regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
  • Create and execute comprehensive test plans, protocols, and reports for medical devices.
  • Perform root cause analysis of non-conformances and implement corrective and preventive actions (CAPA).
  • Conduct internal and external audits to ensure compliance with quality standards and regulatory requirements.
  • Review and approve design control documentation, validation reports, and manufacturing processes.
  • Collaborate with R&D and engineering teams to ensure design outputs meet specifications and quality objectives.
  • Manage supplier quality and conduct supplier audits as necessary.
  • Participate in regulatory submissions and inspections.
  • Train and mentor junior QA personnel.
  • Drive continuous improvement initiatives within the quality assurance framework.
Qualifications:
  • Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical), Science, or a related field.
  • 5+ years of experience in Quality Assurance within the medical device or pharmaceutical industry.
  • Thorough understanding of FDA regulations, ISO 13485, and other relevant international standards.
  • Proven experience in developing and implementing QMS, CAPA, and risk management processes.
  • Strong analytical, problem-solving, and investigative skills.
  • Excellent documentation and technical writing abilities.
  • Experience with statistical methods and tools for quality control.
  • Proficiency in quality assurance software and tools.
  • Ability to work independently and collaboratively in a remote team environment.
  • Strong attention to detail and commitment to accuracy.
This is a critical remote role that offers the opportunity to significantly contribute to the safety and efficacy of life-changing medical devices, supporting operations for the **Shakhura, Northern, BH** manufacturing site.
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Senior Quality Assurance Engineer - Medical Devices

70005 Al Muharraq BHD110000 Annually WhatJobs

Posted 16 days ago

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Job Description

full-time
Our client, a leading innovator in the medical device industry, is seeking a Senior Quality Assurance Engineer for a fully remote position. You will be instrumental in ensuring the highest standards of quality and compliance for our cutting-edge medical products. This role is critical for maintaining product integrity and adherence to stringent regulatory requirements. Responsibilities include developing and implementing comprehensive quality assurance plans, overseeing validation and verification activities, conducting risk assessments, and managing the documentation required for regulatory submissions. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), ISO 13485, and other relevant quality standards for medical devices. Strong analytical skills, meticulous attention to detail, and excellent communication abilities are essential for success in this remote role. You will collaborate closely with R&D, manufacturing, and regulatory affairs teams to ensure that all products meet design specifications and regulatory compliance. Experience with CAPA (Corrective and Preventive Actions) systems, change control processes, and statistical analysis is highly valued. This is a vital role for an individual passionate about patient safety and product excellence.

Responsibilities:
  • Develop, implement, and maintain quality assurance systems and procedures for medical device products.
  • Create and execute comprehensive validation and verification plans for new and existing products.
  • Conduct thorough risk assessments and implement mitigation strategies in accordance with ISO 14971.
  • Ensure compliance with relevant regulatory standards, including FDA QSR, ISO 13485, and CE Marking requirements.
  • Manage and oversee the CAPA (Corrective and Preventive Actions) process, including investigation and closure.
  • Review and approve product design documentation, manufacturing records, and change control requests.
  • Conduct internal audits and support external audits from regulatory bodies and customers.
  • Collaborate with cross-functional teams to address quality issues and implement continuous improvement initiatives.
  • Train and mentor junior quality assurance personnel.
  • Stay up-to-date with evolving regulatory requirements and industry best practices in medical device quality assurance.
Qualifications:
  • Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical) or a related scientific field.
  • Minimum of 6 years of experience in Quality Assurance within the medical device industry.
  • In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
  • Proven experience in developing and executing validation and verification protocols.
  • Strong understanding of risk management principles and tools (e.g., FMEA).
  • Experience with CAPA, change control, and non-conformance management systems.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Strong written and verbal communication skills, with the ability to document and present findings effectively.
  • Ability to work independently and manage projects effectively in a remote environment.
This is an excellent opportunity to contribute to life-saving medical technologies. Join our client's dedicated team. The role is notionally based in Sitra, Capital, BH , but is a fully remote position.
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Remote Senior Quality Assurance Engineer - Medical Devices

223 Busaiteen, Muharraq BHD95000 Annually WhatJobs

Posted 20 days ago

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full-time
Our client, a leading innovator in the medical device industry, is seeking a highly skilled and detail-oriented Senior Quality Assurance Engineer to join their fully remote team. In this critical role, you will be responsible for ensuring the highest standards of quality and compliance for our cutting-edge medical devices. You will design, develop, and implement comprehensive quality assurance strategies, protocols, and test plans throughout the product lifecycle. This is an exceptional opportunity to contribute to the development of life-saving technologies from the convenience of your home office.

Responsibilities:
  • Develop and execute detailed test plans, test cases, and test scripts for software and hardware components of medical devices.
  • Perform rigorous testing, including functional, regression, performance, and usability testing.
  • Identify, document, and track software defects and hardware anomalies using bug tracking systems.
  • Collaborate with cross-functional teams, including R&D, engineering, and regulatory affairs, to define quality requirements and resolve issues.
  • Ensure all product development activities comply with relevant regulatory standards (e.g., FDA, ISO 13485).
  • Participate in design reviews and risk management activities.
  • Develop and implement automated testing strategies where applicable.
  • Analyze test results and provide comprehensive reports to management and project teams.
  • Contribute to the continuous improvement of QA processes and methodologies.
  • Maintain up-to-date knowledge of industry best practices and regulatory requirements.
  • Validate and verify that products meet customer and regulatory requirements.
  • Lead or mentor junior QA engineers as needed.
Qualifications:
  • Bachelor's degree in Engineering (Biomedical, Electrical, Computer), Computer Science, or a related technical field.
  • Minimum of 5 years of experience in Quality Assurance, specifically within the medical device or pharmaceutical industry.
  • In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
  • Strong experience with various testing methodologies and tools (e.g., JIRA, Confluence, TestRail).
  • Proficiency in scripting languages for automation (e.g., Python, Selenium) is a plus.
  • Excellent analytical and problem-solving skills.
  • Superior attention to detail and a commitment to quality.
  • Effective communication and interpersonal skills for cross-functional collaboration.
  • Ability to work autonomously and manage time effectively in a remote setting.
  • Experience with risk management processes (e.g., FMEA) is highly desirable.
  • Certified Quality Engineer (CQE) or equivalent is an advantage.
Join a mission-driven organization dedicated to improving patient outcomes. This remote role offers the chance to work on impactful projects and advance your career in quality assurance for medical devices.
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Regulatory Affairs Executive

New
BHD30000 - BHD60000 Y Zahrawi Medical

Posted today

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Job Description

About Zahrawi Group

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

job Brief

The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time.

ACCOUNTABILITIES

Policies & Procedures:

  • Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

  • Ensure that Zahrawi's products comply with the regulations of the NHRA.
  • Keep up to date with the latest changes in regulatory legislation and guidelines.
  • Liaise and negotiate with regulatory authority to ensure a smooth registration process.
  • Provide advice about regulations to customers/suppliers.
  • Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

Importation Permits:

  • Prepare and apply for the permit document as per the NHRA guidelines and verify the items being imported and the documents required.
  • Apply for the NHRA regulated products permits on the NHRA website as per the specified guidelines.
  • Register and submit the permits for SCE when required.
  • Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
  • Prepare daily report regarding the rejections/ delays for NHRA importation permits and reasons related to that.

Importation Rules & Regulations:

  • Communicate with the existing and new suppliers regarding NHRA importation rules and policies.
  • Upload on the NHRA importation system any new classifications or registration certificates.
  • Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
  • Report any deviation from NHRA guidelines of imported shipments and take the corrective and preventive action accordingly.
  • Review on a regular basis the NHRA importation process of distribution agreements.
  • Ensure that the NHRA license is renewed before expiry date to avoid importation disturbance.
  • Segregate the imported products as per HS code in coordination with logistic team and confirm if products are NHRA regulated or not.
  • Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Pharmacovigilance:

  • Act as the LRPPV (Local Responsible Person for Pharmacovigilance).
  • Perform regulatory intelligence by screening the NHRA websites on a weekly basis.
  • Screen all scientific and medical literature to stay up to date with the latest regulations.
  • Comply with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.
  • Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance)
  • Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer's comments.
  • Fill the Council for International Organizations of Medical Sciences (CIOMS) forms with all the information collected from the ADRs.
  • Send all CIOMS forms to the Manufacturers and the relevant authorities.
  • Manage the Pharmacovigilance process of Zahrawi by and prepare all SOPs, product safety reviews and literature reviews when needed.
  • Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
  • Prepare and review all SOP's Pharmacovigilance plans for all Zahrawi Suppliers.
  • Prepare all Registration and Pharmacovigilance forms and communicating the same to the Suppliers and stakeholders.
  • Provide trainings to all internal divisions on the current Pharmacovigilance Policies & Procedures.

Individual Case Study Reports (ICSRs):

  • Report any spontaneous Individual Case Study Reports (ICSRs) to the Supplier and the Health Authority.
  • Maintain a soft and hard copy of all ICSRs for the future.
  • Track and follow up with all active ICSR reconciliation with the respective authorities.
  • Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

Product Classification & Registration:

  • Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
  • Prepare all required documents to be submitted for Product Classification under NHRA.
  • Prepare all required documents to be submitted for Manufacturing Site registration under NHRA.
  • Prepare all the Dossiers to be submitted to NHRA for product registration.
  • Collect all necessary documents from Supplier to submit for Health Authorities.

Quality Assurance:

  • Monitor all Cold Products from point of receiving until delivery of products to customers along with Data Logger results within the set temperature limits.
  • Examine the packing of goods from the cold storage and monitor the Data Logger Report to ensure consistency.
  • Check the quality of the vehicles, warehouse cleanliness, temperature control mechanism, storage conditions and validity of goods on shelves on a regular basis.
  • Ensure all Zahrawi Cold Vans/Delivery Vehicles, Data Loggers are calibrated regularly and update the temperature mapping of the Warehouse.
  • Ensure all required licenses and registrations as well as calibration renewals are updated before their expiry dates.
  • Review all technical and quality agreements with suppliers and customers on a regular basis.

Warehouse Quality Check:

  • Ensure that the Warehouse & Service Room are kept clean and organized.
  • Ensure that the temperature control mechanism and hygiene standards are maintained in the Warehouse.
  • Ensure a quick and accurate release of shipments from NHRA to avoid any delays in transporting the products to the customer.
  • Ensure that all stock areas are segregated properly into: Dispatching, Receiving, Returns, Hold and Expired and that no mix-up could happen at any time.

Product Quality Check:

  • Ensure that a sample of each batch of products is secured from the WH Assistants and provide the samples along with a progress report and supplier invoice to the Warehouse Operation, QA & RA Manager for NHRA release approval.
  • Check all shipments leaving the Warehouse are sealed and packed properly and if the vehicle is fit for transporting the products.
  • Compile all Quality Inspection Forms prepared by the Sr. Driver & Fleet Coordinator and prepare a monthly report.
  • Generate a discrepancy report to the Warehouse Operation, QA & RA Manager for MOH release approval for any late findings (excess, damaged or expired goods) in the shipment.

Audit:

  • Prepare any documentation needed for internal and external audits.
  • File all documents in the corresponding files to ensure all are available and are correct.
  • Evaluate the suggestions after the audit and implement them when possible.

Admin:

  • Develop a professional relationship with the NHRA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
  • Represent Zahrawi in NHRA and different authorities.
  • Negotiate with regulatory authorities for marketing authorization.
  • Attend and respond to calls and emails from customers, the Sales team and other support staff.
  • Assist the Warehouse Coordinators with relevant documents when requested.
  • Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to NHRA importation.
  • Keep track of all registration application on Zahrawi's tracking system.
  • Record all active Zahrawi licenses on the Shared folder and ensure they are updated.

REQUIREMENTS

  • Education: Bachelors Degree in Pharmacy
  • Additional details:
  • Candidates must be based in Bahrain and should be willing to move to company visa (when applicable)
  • Candidates must have a valid Pharmacist license
  • Experience: 3 + years of relevant experience in regulatory affairs within Bahrain.
  • Job Specific Skills: Excellent Interpersonal Skills & Good English – Good computer skills in Ms. Office (Excel– ERP/Oracle system) - Knowledge about Regulatory Affairs, Product Classification and Importation Regulations as per NHRA

Location: Bahrain - Manama

Job Type: FULLTIME

Job Posting Date:

Division/Department: Warehouse Operation and Distribution

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Regulatory Affairs Specialist

23456 Al Ghurayfah BHD105000 Annually WhatJobs

Posted 11 days ago

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Job Description

full-time
Our client is actively searching for a dedicated and detail-oriented Regulatory Affairs Specialist to join their fully remote pharmaceutical team. In this critical role, you will be responsible for ensuring that all products meet the stringent regulatory requirements of various international markets. Your expertise will be vital in navigating the complex landscape of pharmaceutical regulations, from initial product development through to marketing authorization and lifecycle management. Key responsibilities include preparing and submitting regulatory dossiers (e.g., IND, NDA, MAA), responding to queries from health authorities, and staying abreast of evolving regulatory guidelines and legislation worldwide. You will liaise with internal departments, including R&D, Quality Assurance, and Commercial, as well as external partners and regulatory agencies, all within a remote work environment. A strong understanding of global regulatory submission processes and experience with electronic submission platforms are essential. The ability to analyze complex scientific data and translate it into clear, concise regulatory documents is a must. You will play a key role in developing regulatory strategies to support product approval and commercialization. Excellent written and verbal communication skills are paramount, as is a meticulous approach to documentation and compliance. This position requires a proactive individual with strong analytical and problem-solving abilities who thrives in an independent, remote setting. A Bachelor's or Master's degree in a relevant scientific or technical field (e.g., pharmacy, chemistry, biology) and a minimum of 5 years of experience in pharmaceutical regulatory affairs are required. Experience with specific therapeutic areas or product types may be an advantage. This is an exceptional opportunity to contribute to global health initiatives by facilitating the timely access of innovative medicines to patients, all while enjoying the flexibility of a remote career.
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Pharmaceutical Regulatory Affairs Specialist

1015 Northern, Northern BHD70000 Annually WhatJobs

Posted today

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a diligent and knowledgeable Pharmaceutical Regulatory Affairs Specialist to ensure compliance with all relevant regulations and guidelines. This critical role involves navigating the complex regulatory landscape for drug development, approval, and lifecycle management. The ideal candidate will possess a strong understanding of pharmaceutical regulations, excellent analytical skills, and meticulous attention to detail.

Key Responsibilities:
  • Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities.
  • Maintain a thorough understanding of current and evolving national and international pharmaceutical regulations.
  • Liaise with regulatory agencies to facilitate the review and approval process for pharmaceutical products.
  • Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
  • Monitor regulatory intelligence and assess the impact of new regulations on company products and strategies.
  • Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant quality standards.
  • Manage post-approval regulatory activities, such as annual reports and safety updates.
  • Review and approve promotional materials and labeling to ensure regulatory compliance.
  • Participate in regulatory audits and inspections.
  • Maintain accurate and organized regulatory databases and filing systems.
Required Qualifications:
  • Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field. A Master's degree is advantageous.
  • Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
  • In-depth knowledge of regulatory submission processes and requirements in key markets.
  • Familiarity with ICH guidelines and regional regulatory frameworks.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Excellent written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
  • Meticulous attention to detail and a commitment to accuracy.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Proficiency in regulatory information management systems is a plus.
  • Must be able to work effectively within a hybrid model in **Shakhura, Northern, BH**.
This is an excellent opportunity for a regulatory professional to contribute to the success of a reputable pharmaceutical company in **Shakhura, Northern, BH**. Our client offers a competitive salary and benefits package.
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Senior Regulatory Affairs Specialist

98001 Galali BHD105000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client is a prominent international pharmaceutical company committed to developing and delivering life-changing medicines. We are seeking a highly knowledgeable and experienced Senior Regulatory Affairs Specialist to join our dedicated team at our **Sanad, Capital, BH** location. This role is crucial for ensuring that our products meet all necessary regulatory requirements for market approval and continued compliance in various global markets. You will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities, including applications for new drug approvals, variations, and renewals. Your duties will involve staying abreast of evolving regulatory landscapes, providing expert advice to cross-functional teams (e.g., R&D, Clinical Operations, Quality Assurance), and managing regulatory submissions throughout their lifecycle. You will conduct regulatory intelligence activities, assess the impact of new regulations, and contribute to the development of regulatory strategies. The ideal candidate will have a strong scientific background, typically with a degree in a life science, chemistry, pharmacy, or a related field, and a minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Proven experience with major regulatory agencies (e.g., FDA, EMA, MHRA) and knowledge of ICH guidelines are essential. Excellent written and verbal communication skills, meticulous attention to detail, and strong project management abilities are required. You should be adept at navigating complex regulatory frameworks and effectively communicating scientific and regulatory information. This position offers a stimulating environment where you can contribute significantly to bringing essential medicines to patients worldwide.
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Senior Regulatory Affairs Specialist

622 Gudaibiya, Capital BHD90000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a leading innovator in the (mention relevant industry, e.g., technology, healthcare) sector, is seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join their expanding team. This is a fully remote position, offering the opportunity to contribute to critical projects from anywhere. The ideal candidate will possess a comprehensive understanding of regulatory frameworks, compliance strategies, and submission processes relevant to our industry. You will play a crucial role in ensuring our products and services meet all necessary legal and regulatory requirements, facilitating market entry and ongoing compliance.

Key Responsibilities:
  • Develop and implement regulatory strategies for new and existing products/services in alignment with global compliance standards.
  • Prepare, review, and submit regulatory documentation to relevant authorities (e.g., FDA, EMA, local regulatory bodies).
  • Interpret and communicate complex regulatory requirements to internal teams, including R&D, product development, and marketing.
  • Monitor changes in regulatory landscapes and proactively assess their impact on the company's operations and product portfolio.
  • Act as the primary point of contact with regulatory agencies, managing communications and addressing inquiries.
  • Conduct regulatory audits and ensure internal compliance with established procedures and guidelines.
  • Identify potential regulatory risks and develop mitigation strategies.
  • Collaborate with cross-functional teams to ensure product development and manufacturing processes adhere to regulatory standards.
  • Maintain accurate and organized regulatory records and databases.
  • Contribute to the development of regulatory policies and standard operating procedures (SOPs).
  • Provide training and guidance to internal stakeholders on regulatory matters.
  • Support post-market surveillance activities and manage regulatory reporting requirements.

Qualifications:
  • Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
  • Minimum of 6 years of progressive experience in regulatory affairs, preferably within the (mention relevant industry) sector.
  • Proven track record of successful regulatory submissions and approvals.
  • In-depth knowledge of global regulatory requirements and guidelines pertinent to our industry.
  • Excellent understanding of product lifecycle management and associated regulatory considerations.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication skills, with the ability to present complex information clearly and persuasively.
  • Proficiency in regulatory information management systems and relevant software.
  • Ability to work independently, manage priorities effectively, and meet tight deadlines in a remote environment.
  • Detail-oriented with a high degree of accuracy.
  • Experience in international regulatory affairs is a significant advantage.

This fully remote role offers the chance to significantly impact regulatory strategy and compliance from your home office.
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