364 Medical Devices jobs in Bahrain

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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.

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

• 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.

• 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**.

• 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.

• 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.