Meril, a global leader in medical device innovation, is seeking a skilled Regulatory Affairs Officer/Executive to join their team in Vapi, Gujarat. If you have a strong background in medical device compliance, regulatory submissions, and technical documentation, this is an excellent opportunity to grow your career in a dynamic and fast-paced environment.
Key Responsibilities:
- Lead medical device testing in compliance with international standards (ISO, FDA, CE, etc.) and risk management frameworks.
- Prepare and review technical documentation, regulatory dossiers, and submissions for global markets.
- Collaborate with R&D, Quality Assurance, and Product Management teams to ensure regulatory compliance.
- Manage product data, test reports, and design control documentation.
- Stay updated with changing regulatory guidelines and implement necessary changes.
- Support audits and regulatory inspections as required.
Qualifications & Skills Required:
- Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Biomedical Engineering, or related fields.
- 1-3 years of experience in Regulatory Affairs (Medical Devices/Pharma preferred).
- Strong knowledge of ISO 13485, MDR, FDA 21 CFR, and other global regulations.
- Excellent technical writing, communication, and project management skills.
- Ability to work in a fast-paced, cross-functional environment.
Why Join Meril?
✅ Global Leader in Medical Technology – Work on cutting-edge medical devices impacting healthcare worldwide.
✅ Career Growth & Learning – Opportunities for professional development in regulatory compliance.
✅ Collaborative Work Culture – Be part of a dynamic and innovative team.
✅ Competitive Salary & Benefits – Attractive compensation with health benefits and incentives.
About Meril
Meril Life Sciences is a leading global medical device company specializing in innovative healthcare solutions, including stents, orthopaedic implants, surgical instruments, and diagnostic technologies. With a strong presence in over 100 countries, Meril is committed to improving patient care through advanced medical innovations.
📍 Website: www.merillife.com
How to Apply?
Interested candidates can share their updated resume at:
📧 sushma.vashi@merillife.com
📧 rohan.lapsiwala@merillife.com
Subject Line: “Application for Officer/Executive – Regulatory Affairs, Vapi”
