Position: Medical Regulatory Engineer
Location: Pune, India
Experience: 5–7 Years
Industry: Medical Devices
Job Summary
We are seeking a Medical Regulatory Engineer with strong experience supporting global regulatory compliance for medical devices. The ideal candidate will have hands-on experience preparing regulatory documentation, supporting submissions, and ensuring compliance with FDA, EU MDR, and global medical device regulations.
Key Responsibilities
- Prepare, review, and maintain regulatory documentation for medical devices.
- Support product registrations and regulatory submissions for global markets.
- Ensure compliance with FDA and European regulatory requirements.
- Participate in product lifecycle regulatory activities.
- Review technical documentation and labeling.
- Support internal and external regulatory audits.
- Work closely with Quality, R&D, Clinical, and Manufacturing teams.
- Monitor changes in global regulations and assess their impact.
- Support design control documentation and regulatory strategies.
Required Skills
- 5–7 years of Medical Device Regulatory Affairs experience.
- Hands-on experience with:
- FDA 21 CFR Part 820
- FDA Quality System Regulation (QSR)
- EU MDR (2017/745)
- ISO 13485
- Technical Documentation
- Design History File (DHF)
- Device Master Record (DMR)
- Risk Management Documentation
- Experience preparing regulatory submissions.
- Strong documentation and analytical skills.
Preferred Qualifications
Experience with the following regulations and frameworks is highly desirable:
- FDA 21 CFR Part 820
- EU MDR 2017/745
- HIPAA (Health Insurance Portability and Accountability Act)
- GDPR (General Data Protection Regulation) (recommended in place of "CPA" if referring to data privacy; if you meant the California Privacy Act, specify CCPA/CPRA)
- ISO 14971 (Risk Management)
- IEC 62304 (Medical Device Software) – if applicable
- IEC 60601 – if applicable
- Regulatory submissions such as 510(k), Technical Files, CE Marking, and global product registrations.
Education
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electronics Engineering, Life Sciences, or a related discipline.
Preferred Candidate Profile
- Medical Device industry experience is mandatory.
- Strong understanding of global regulatory requirements.
- Excellent technical documentation and communication skills.
- Ability to work effectively with cross-functional global teams.
- Experience supporting regulatory audits and compliance activities.
Pay: ₹60,000.00 - ₹70,000.00 per month
Work Location: In person
