Assistant Manager Regulatory affairs (Medical Device)

Biotech Healthcare; Ahmedabad District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Biotech Healthcare is seeking a Regulatory Affairs professional to prepare, review, and maintain regulatory documents across international requirements. The role ensures timely TMF updates, PMS activities, and audit readiness while collaborating with internal teams for compliant product registrations.

The candidate will manage technical files, risk management, and evaluation reports, leveraging strong MS Office skills and regulatory databases to support cross-functional regulatory initiatives.

Qualifications

• Experience of 6–9 years in Regulatory Affairs within pharma/biotech/medical devices.
• Knowledge of international regulatory guidelines (EU MDR, US FDA, ISO standards).
• Experience in dossier preparation, technical file management, and compliance documentation.
• Proficient in MS Office and regulatory database searches.

Responsibilities

• Prepare and maintain TMFs for all products with regulatory accuracy.
• Conduct periodic TMF reviews to ensure content consistency.
• Prepare/update technical documents such as Risk Management Reports, Preclinical & Biological Evaluations, and ESRs.
• Ensure timely PMS reports and integrate findings into risk management.
• Support audit readiness with complete, accurate technical files.
• Review and compile product registration dossiers per country requirements.
• Collaborate with RA team to monitor compliance and provide updates.
• Provide regulatory support to cross-functional teams.

Skills

Regulatory affairs

Dossier preparation

TMF management

PMS documentation

Audit readiness

Regulatory intelligence

Cross-functional collaboration

Education

Graduate/ Postgraduate in Pharmacy, Biotechnology, Life Sciences

Tools

MS Office

Regulatory database searches

Job description

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

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

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