Head - RA (Regulatory Affairs)

Prominent Consultant

10 - 20 years

15 - 40 Lacs

ahmedabad vadodara

Posted:3 days ago| Platform:

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Skills Required

medical devices regulatory affairs tga compliance iso parenteral sterile ent injection ra medical equipment usfda pmda mdsap cdsco orthopedics ema implants injectables ophthalmology kfda

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position :- Head - RA (Regulatory Affairs)

strategic and experienced Regulatory Affairs leader

primary liaison with global regulatory bodies

Key Responsibilities :-

Regulatory Strategy & Submissions
- Develop global regulatory strategies and lead dossier submissions.
- Manage interactions with USFDA, EMA, CDSCO, PMDA, TGA, KFDA, MDSAP markets.
- Ensure timely approvals and lifecycle management.
Compliance & Quality
- Ensure compliance with EU-MDR, PMDA, MDSAP.
- Support audits, inspections, and CAPA.
- Collaborate with QA, R&D, Manufacturing, Clinical teams.
Technical Documentation
- Oversee DMFs, DHFs, risk files, validations, clinical evidence.
- Review/approve change controls.
Regulatory Intelligence
- Track global standards (ISO 13485, 14971, 14155).
- Update SOPs/policies and train teams.
PMS & Vigilance
- Lead complaint handling, adverse event reporting, FSCA, trend analysis.
- Ensure global vigilance compliance.
Risk Management
- Lead ISO 14971 risk assessments and risk–benefit approvals.

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