ZEISS India is inviting applications for the position of Regulatory Affairs Specialist in Bangalore, Karnataka. This is an excellent opportunity for experienced Regulatory Affairs professionals with expertise in medical devices, EU MDR, US FDA 510(k), technical documentation, and global regulatory submissions. The role involves supporting regulatory strategies for software and hardware medical devices while collaborating with cross-functional global teams.
If you have experience in Medical Device Regulatory Affairs, technical documentation, and international product registrations, this ZEISS Regulatory Affairs Specialist job could be an ideal next career move.
Job Details
| Particular | Details |
|---|---|
| Company | ZEISS India |
| Position | Regulatory Affairs Specialist |
| Job Type | Full-Time |
| Location | Bangalore, Karnataka |
| Experience | 3โ5 Years |
| Industry | Medical Devices |
| Department | Regulatory Affairs |
Key Responsibilities
- Prepare regulatory submissions for Class I, IIa, and IIb medical devices.
- Support compliance with EU MDR and US FDA 510(k) regulations.
- Assist country-specific registrations including NMPA and global markets.
- Prepare technical documentation including STED, GSPR, DoC, CER, and PMS reports.
- Evaluate regulatory impact of design changes and product updates.
- Coordinate with Product Management, Clinical Affairs, QA, and Program teams.
- Monitor post-market surveillance activities and regulatory commitments.
- Respond to regulatory authority queries.
- Identify regulatory risks and recommend mitigation strategies.
- Support digitalization and process improvement initiatives using regulatory tools.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field.
- 3โ5 years of Regulatory Affairs experience in Medical Devices.
- Strong knowledge of EU MDR and US FDA 510(k).
- Experience with CER, PMS, STED, GSPR, and technical documentation.
- Exposure to international regulatory registrations.
- RCC certification is an added advantage.
- Strong MS Office and documentation skills.
Preferred Skills
- Medical Device Regulatory Affairs
- EU MDR
- US FDA 510(k)
- Technical Documentation
- STED
- CER
- PMS
- GSPR
- Product Registration
- Regulatory Compliance
- Change Control
- Cross-functional Collaboration
- Documentation Management
- Risk Assessment
Why Join ZEISS?
- Work with one of the world’s leading medical technology companies.
- Exposure to global regulatory submissions.
- International cross-functional collaboration.
- Career growth in Medical Device Regulatory Affairs.
- Opportunity to work on innovative healthcare technologies.
- Inclusive work culture with continuous learning opportunities.
Salary (Expected)
Based on industry standards, the expected annual salary for this role is:
โน12 LPA โ โน20 LPA (Approx.)
Actual compensation depends on qualifications, experience, and interview performance.
How to Apply
