On-site
Full Time
Job Profile: Regulatory Affairs Manager
Experience: 10+ years
Location: Delhi NCR
Industry: Medical Device/ Pharma
Job Description:
Regulatory Affairs & Quality Compliance (MDR 2017) – End-to-end management of
regulatory dossiers, licensing, renewals, labeling compliance, and post-market
surveillance.
Cross-Functional Coordination – Ensures product lifecycle compliance, including
change control and audit readiness.
Issue & Risk Management – Leads regulatory audits, manages non-compliance, and
drives quick resolution of critical issues.
Government Liaison – Strong engagement with regulatory authorities, ministries, NPPA,
CPCB, DOP, BIS, and Materiovigilance.
Policy & Advocacy – Tracks regulatory developments, prepares policy briefs/position
papers, and supports government affairs strategy.
Quality & Safety Oversight – Manages recalls, complaints, adverse event reporting, and
documentation compliance.
Support for GeM & Tenders – Provides regulatory inputs for government procurement
and tender submissions.
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