Job Title: Regulatory Affairs Manager
Company: Thermo Fisher Scientific
Location: Bangalore, Karnataka, India
Job Type: Full-Time, Onsite
Category: Quality & Regulatory
Company Overview
Thermo Fisher Scientific’s quality teams focus on accuracy, safety, and effectiveness of products and services. Quality professionals collaborate on global projects, ensuring compliance and excellence while supporting individual growth and career development.
Work Schedule & Environment
Work Schedule: Other (as per project requirements)
Environment: Office-based
Job Summary
The Regulatory Affairs Manager is responsible for premarket approvals and post-market vigilance of In-Vitro Diagnostic (IVD) and Medical Devices within the LSG South Asia (SA) market. The role provides regulatory expertise, supports cross-functional project teams, and ensures compliance with Indian and regional regulations.
Key Responsibilities
Conduct regulatory submissions for LSG IVD and Medical Devices in South Asia, ensuring compliance with timelines and standards
Support implementation of regulatory activities at the LSG Indian plant (QMS/GMP compliance)
Collaborate with R&D, Operations, QA, and Product Managers to meet regulatory and compliance requirements
Conduct regulatory investigations and analyses, define strategies, and update cross-functional teams
Prepare and manage technical files/dossiers for regulatory products and global registration applications
Lead local performance evaluations, tests, and clinical studies to support product registration in India
Participate in Animal Health regulatory submissions and support distributed teams
Coordinate post-market surveillance, resolve technical complaints, and implement corrective actions
Review advertisement materials for compliance with MD/IVD regulations in South Asia
Analyze new and existing regulations, preparing impact assessments for LSG projects
Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization
Participate in regulatory/quality audits, exhibitions, and conferences
Establish and maintain networks with consultants, policymakers, and regulatory agencies, including Indian CDSCO
Perform other tasks as assigned by line manager
Minimum Requirements
Education & Qualifications
Bachelor’s degree or higher in Engineering, Sciences, or Medicine
10+ years of experience in regulatory affairs for Medical Devices and/or IVDs, with strong knowledge of Indian CDSCO regulations
Skills & Abilities
Comprehensive understanding of regulations, standards, and guidelines for IVDs and Medical Devices in South Asia
Acute awareness of regulatory changes and strong regulatory/strategic analysis skills
Strong planning and organizational skills for regulatory submissions and project management
Excellent communication skills (written, verbal, and presentation)
Strong project management and leadership skills
Analytical, proactive, and resourceful problem-solving abilities
Ability to work under pressure and manage flexible hours
Comfortable with ambiguity and change, providing mentorship in uncertain regulatory environments
Experience in post-market surveillance and advertisement review
Ability to establish networks with consultants, policymakers, and regulatory agencies
Proficiency in cross-functional collaboration to meet regulatory and compliance requirements
Gujarat :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
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