Rxcruit

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.