Position: Regulatory Affairs & Quality Assurance (RA/QA) Specialist

Industry: Medical Devices

Experience: 4–8 Years

Location: Chennai

Job Summary

We are seeking a highly motivated Regulatory Affairs & Quality Assurance (RA/QA) Specialist with strong experience in medical device regulations and quality management systems. The ideal candidate will be responsible for preparing and maintaining technical documentation, supporting regulatory submissions, ensuring compliance with EU MDR 2017/745, and contributing to quality and risk management activities throughout the product lifecycle.

Key ResponsibilitiesRegulatory Affairs

- Prepare, review, and maintain Technical Documentation/Technical Files in compliance with EU MDR 2017/745.
- Develop and update documentation as per Annex II and Annex III requirements.
- Create and maintain GSPR (General Safety and Performance Requirements) checklists and traceability matrices.
- Support regulatory submissions, audits, and interactions with Notified Bodies.
- Ensure compliance with applicable regulations, standards, and guidance documents.

Quality Assurance
- Support and maintain the Quality Management System (QMS) in accordance with ISO 13485.
- Participate in internal audits, CAPA activities, change control, and document control processes.
- Support supplier quality management and quality compliance initiatives.

Risk Management & Product Development
- Perform and maintain Risk Management documentation in accordance with ISO 14971.
- Collaborate with cross-functional teams to identify hazards, assess risks, and implement risk control measures.
- Support Design History File (DHF)



development and maintenance throughout the product lifecycle.
- Review Verification & Validation (V&V;) documentation to ensure compliance with design and regulatory requirements.

Clinical & Post-Market Activities
- Prepare and maintain Clinical Evaluation Reports (CER) in accordance with EU MDR requirements.
- Support Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) activities.
- Analyze post-market data and contribute to continuous product improvement and regulatory compliance.

Required Qualifications
- Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Biotechnology, Pharmacy, Mechanical Engineering, or a related field.
- 3–8 years of experience in Regulatory Affairs and/or Quality Assurance within the Medical Device industry.
- Strong understanding of EU MDR 2017/745 and ISO 13485 requirements.
- Experience in Technical File preparation and regulatory documentation.
- Knowledge of ISO 14971 Risk Management principles and methodologies.
- Experience preparing or supporting CER, PMCF, DHF, and V&V; documentation.
- Solid documentation, analytical, and communication skills.

Preferred Skills
- EU MDR 2017/745
- Technical File Preparation
- Annex II & Annex III Documentation
- GSPR Compliance
- ISO 14971 Risk Management
- Clinical Evaluation Report (CER)
- Post Market Clinical Follow-up (PMCF)
- Design History File (DHF)
- Verification & Validation (V&V;)
- ISO 13485 Quality Management System
- CAPA, Internal Audits, Change Control
- Medical Device Regulatory Submissions

Interested candidate pls share your resume or call at +91 93451 08018 Pay: ₹255,242.59 - ₹1,231,037.05 per year

Work Location: In person

📌 QA/RA (Chennai)
🏢 Hirely
📍 Chennai