Regulatory Affairs Manager

Fresher

Not Disclosed

Early Applicant

Job Description

Key Responsibilities1. Regulatory Strategy & Compliance

Develop and implement regulatory strategies for product approvals in India and global markets.
Ensure compliance with:
Medical Device Rules, 2017 (India)
ISO 13485:2016
EU MDR/IVDR (2017/745, 2017/746)
US FDA (21 CFR Part 820)
Interpret regulatory requirements and provide guidance to cross-functional teams.

2. Product Registration & Submissions

Prepare and submit regulatory dossiers (e.g., MD-3, MD-5, MD-7, MD-12, MD-13).
Conduct EU MDR assessments and prepare Technical Files.
Handle product registration for IVD reagents/kits with CDSCO and other regulatory bodies.
Compile technical documentation, including:
Device Master File (DMF)
Plant Master File (PMF)
Performance Evaluation Reports
Risk Management Files (ISO 14971)

3. Liaison with Regulatory Authorities

Act as a point of contact with regulatory authorities (e.g., CDSCO, Notified Bodies).
Respond to queries, deficiency letters, and audit observations.
Coordinate inspections and regulatory audits.

4. Lifecycle Management

5. Documentation & Compliance Control

Review and approve labeling, IFU (Instructions for Use), and packaging compliance.
Ensure alignment of technical documents with regulatory requirements.
Maintain regulatory documentation and records.

6. Post-Market Surveillance (PMS) & PMCF