Compliance Documentation Expert

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.
• 6–9 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

summarize and integratefindings into PMS and Risk Management documentation.

Functional Skills Required

Behavioral Skills Required

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.