Position : Regulatory Affairs - Officer (Medical Device)
Job Location : Ahmedabad
(5 Days Working)
Reports To : Manager - RA
Key Responsibilities:
Regulatory:
- Manage and maintain regulatory data in internal systems, MoH portals & EUDAMED
- Review technical documentation as per CE / MDR requirements
- Verify authenticity of CE, ISO & other certificates
Quality Assurance:
- Conduct desktop evaluation of manufacturers
- Review product documentation (specifications, CER, PMS, COA, etc.)
- Coordinate with manufacturers for compliance & product evaluation
- Develop and maintain SOPs & ensure documentation control
Operations & Support:
- Support QMS improvement and regulatory alignment
- Coordinate with QA, procurement & sales for product-related matters
- Handle deviations, claims, and product reviews
- Support team training and knowledge sharing
- Travel internationally as required
Qualifications & Experience:
- Bachelor's/Master's in Life Sciences, Regulatory Affairs, Pharma, Biomedical Engineering, or related field
- 3–5 years experience in Medical Devices (RA / QA / QC / Documentation)
- Exposure to international work environment preferred
Key Skills & Competencies:
- Hands-on experience with Class I & II medical devices
- Strong knowledge of ISO 13485, EU MDR, CE & global regulatory standards
- Experience reviewing regulatory documents (CE, FSC, DoC, IFU, PMS, CER, UDI, etc.)
- Understanding of Quality Management Systems (QMS)
- Excellent English communication (written & verbal)
- Detail-oriented, structured, and proactive
- Ability to coordinate with manufacturers for product evaluation
- Proficient in MS Office (Word, Excel, PowerPoint)
- Ability to work independently and in multicultural teams
Languages:
- English (mandatory)
- Italian (preferred)
Contact
Rina Arun
[Confidential Information]
+91 9904322770
