Are you an experienced professional in regulatory affairs with a strong background in medical devices? MJ Surgical, a leading manufacturer and exporter of orthopedic implants and instruments, is seeking a dedicated Regulatory Affairs Specialist to join their team in Ahmedabad, Gujarat.
This role is perfect for candidates passionate about ensuring compliance with global standards like EU MDR, USFDA, and ISO 13485. As a key player in the fast-growing orthopedic medical device industry, MJ Surgical offers an opportunity to contribute to high-quality product development and international market access.
Roles & Responsibilities
- Prepare and manage documentation for ISO 13485 certification, CE marking (as per EU MDR), and USFDA submissions.
- Develop and maintain Technical Master Files for medical device products.
- Create and update Clinical Evaluation Reports (CERs) in compliance with EU MDR requirements.
- Handle Design & Development files along with Risk Management documentation as per EU MDR guidelines.
- Maintain and implement Quality Management Systems (QMS) for medical devices.
- Prepare and submit reports to regulatory authorities in India, Europe, and the US.
- Conduct internal quality audits to ensure ongoing compliance.
- Stay updated with regulations under European CE (MDD & MDR) and USFDA 510(k) pathways.
Required Qualifications & Skills
- Educational Background: B.Pharm / M.Pharm or Bachelor’s/Master’s degree in Biomedical Engineering / relevant Science discipline, with specialized training in Medical Devices Regulatory Affairs.
- Experience: 3-5 years in regulatory affairs specifically for medical devices (required).
- Key Skills:
- Strong documentation handling and attention to detail.
- Excellent written and verbal communication abilities.
- Proficiency in computer applications and MS Office suite.
- In-depth knowledge of:
- European CE marking (MDD and MDR).
- USFDA 510(k) submission process.
- Quality Management Systems (QMS) for medical devices.
Salary & Benefits
- Salary Range: ₹30,000 – ₹80,000 per month (based on experience and interview performance).
- Additional Benefits:
- Leave encashment
- Provident Fund (PF)
- Yearly performance bonus
This position offers competitive compensation and growth opportunities in a company certified with CE (European), MDSAP, ISO 13485:2016, EN-ISO 13485:2016, and Indian MDR standards.
How to Apply
Interested candidates meeting the above criteria are encouraged to apply directly through the company’s career channels or LinkedIn profile. Prepare your updated resume highlighting relevant medical device regulatory experience and send it to the HR team at MJ Surgical. Shortlisted applicants will be contacted for interviews.
Don’t miss this chance to advance your career in the orthopedic medical devices sector with a reputed organization like MJ Surgical!
