Assistant Manager Regulatory affairs (Medical Device)

Role Objective

Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and contributes to audit readiness. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization.

Desired Candidate Profile

• Graduate/Postgraduate in Pharmacy, Biotechnology, Life Sciences, or a related discipline.
• 69 years of experience in Regulatory Affairs, preferably in the pharmaceutical, biotechnology, or medical devices industry.
• Strong understanding of international regulatory guidelines (e.g., EU MDR, US FDA, ISO standards).
• Demonstrated experience in dossier preparation, technical file management, and compliance documentation.
• Proficiency in MS Office and regulatory database searches.

Role & Responsibilities

1. Prepare and maintain Technical Master Files (TMFs) for all products, ensuring timely updates and regulatory accuracy.
2. Conduct scheduled reviews of TMFs to ensure consistency and alignment of technical content across product categories.
3. Prepare and update critical technical documents, including Risk Management Reports, Preclinical and Biological Evaluations, and Evaluation Summary Reports (ESRs).
4. Ensure timely preparation and updates of Post-Market Surveillance (PMS) reports, incorporating relevant findings.
5. Perform periodic searches of MAUDE and other relevant country-specific databases; summarize and integrate findings into PMS and Risk Management documentation.
6. Support audit preparations by ensuring completeness, accuracy, and readiness of technical files.
7. Review, compile, and finalize product registration dossiers in line with country-specific regulatory requirements.
8. Collaborate with the Regulatory Affairs team to monitor compliance activities, track file status, and provide daily progress updates.
9. Provide regulatory and documentation support to cross-functional teams in line with organizational priorities.

Functional Skills Required

• In-depth knowledge of regulatory requirements and submission processes across multiple markets.
• Expertise in the preparation of dossiers, TMFs, PMS, and Risk Management documentation.
• Strong documentation, review, and editing skills.
• Familiarity with regulatory intelligence tools and database search methodologies.
• Ability to prepare audit-ready documentation.

Behavioral Skills Required

• Strong attention to detail with high accuracy.
• Effective communication and collaboration skills for cross-functional teamwork.
• Ability to prioritize tasks and manage timelines under pressure.
• Proactive problem-solving and decision-making skills.
• Accountability and ownership of assigned deliverables.

Team Size to be Handled:

Individual Contributor role, reporting to the Sr. Manager RA.

Important Links:

Website:https://biotechhealthcare.com/

LinkedIn:https://www.linkedin.com/company/biotechhealthcare/

Instagram:Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.