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Regulatory Affairs

2 weeks ago

Ahmedabad, India Maven Profcon Services Full time

**Experience**: 0 - 5 Yrs.

**Qualification**: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

**Job Profile**: As a Regulatory Affairs executive, you shall:

- Prepare technical documentation for various national (Indian MDR) and international regulations (CE, USFDA, UKCA, Country registrations) applicable to a wide range of medical devices on project basis.
- Clinical evaluation writing
- Gap analysis of client documentation and recommendation/working on changes
- Communication with client on routine basis for project related information and data
- Collect, review and integrate data in regulatory submissions.
- Advise manufacturers on regulatory requirements when needed
- Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation
- Attend to client queries, doubts and review comments
- Audit client premises when required and also supporting client for certification audits
- Departmental activities, discussions and research for continual improvement
- Keep up with updates in standards, guidelines and other regulatory requirements
- Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.