Description:
Role Objective
The Assistant Manager - Regulatory Affairs will lead the preparation, review, and maintenance of regulatory documentation in compliance with EU MDR, US FDA, and ISO standards. The role ensures regulatory readiness, supports global product registrations, manages post-market surveillance (PMS) activities, and drives audit preparedness across business units.
Key Responsibilities
Regulatory Documentation & Compliance
- Prepare, update, and maintain Technical Master Files (TMFs) for all product categories.
- Conduct regular TMF reviews to ensure accuracy and compliance with global standards.
- Prepare and review technical documents such as Risk Management Reports, Preclinical Evaluations, Biological Evaluations, and Evaluation Summary Reports (ESRs).
- Manage Post-Market Surveillance (PMS) activities, integrating data from sources like MAUDE and other country-specific databases.
Regulatory Submissions & Product Registrations
- Prepare and compile product registration dossiers in line with country-specific and international requirements.
- Coordinate submissions and approvals across multiple markets, ensuring timely updates and compliance tracking.
Audit & Quality Readiness
- Ensure documentation and TMFs are audit-ready at all times.
- Support internal and external regulatory audits with complete and accurate documentation.
Cross-functional Collaboration
- Collaborate with R&D, Quality, Manufacturing, and Clinical teams to align on regulatory strategies and documentation requirements.
- Provide daily progress updates and compliance tracking to senior management.
Desired Candidate Profile
Qualification: Graduate / Postgraduate in Regulatory affairs, Life Sciences, or related field.
Experience: 7-9 years of experience in Regulatory Affairs within Pharma, Biotech, or Medical Devices.
Expertise:
- Strong understanding of international regulatory frameworks (EU MDR, US FDA, ISO).
- Hands-on experience in dossier preparation, technical file management, risk documentation, and PMS reports.
- Proficiency in MS Office and regulatory database searches.
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