QA/RA(Quality Assurance and Regulatory affairs)Specialist

We are looking for an experienced Medical Device Regulatory Affairs Specialist to manage regulatory documentation, submissions, risk management, and compliance activities for medical devices. The candidate will be responsible for preparing Technical Documentation/Technical Files and ensuring compliance with global regulations and standards including EU MDR, ISO 13485, ISO 14971, FDA 21 CFR, and ISO 10993.

Key Responsibilities

Technical Documentation & Regulatory Submissions

• Prepare, compile, review, and maintain Technical Documentation/Technical Files for medical devices.
• Develop and review Device Description, Intended Use, Labeling, and GSPR documentation.
• Support regulatory submissions for EU MDR, CE Marking, FDA 510(k), and other international markets.
• Coordinate with cross-functional teams for regulatory submission requirements.

Risk Management

• Develop and maintain Risk Management Files as per ISO 14971.
• Conduct hazard analysis, risk evaluation, risk control, and benefit-risk assessments.
• Ensure traceability between risks, product requirements, verification activities, and mitigations.

Clinical Evaluation & Post-Market Activities

• Prepare and update Clinical Evaluation Reports (CER) in accordance with EU MDR.
• Support Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities.
• Review post-market data, complaints, and vigilance reports for regulatory compliance.

Verification & Validation

• Review Verification and Validation (V&V) reports for regulatory and design compliance.
• Ensure traceability between product requirements and validation evidence.
• Support software validation documentation, wherever applicable.

Quality & Compliance

• Ensure compliance with ISO 13485 Quality Management System requirements.
• Participate in internal and external audits.
• Monitor and evaluate changes in global medical device regulations and applicable standards.
• Maintain accurate regulatory records and ensure effective document control.

Required Qualifications

• Bachelors or Masters degree in Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• 4+ years of experience in Medical Device Regulatory Affairs.
• Hands-on experience in preparing and maintaining Technical Files/Technical Documentation.
• Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, and ISO 10993.
• Experience with CER, PMS, PMCF, and Risk Management documentation.
• Strong technical writing, documentation, and document control skills.