Regulatory Affairs Manager
Location: Bangalore, Karnataka, India
Job ID: R-01321070
Job Type: Full-time
Category: Quality & Regulatory
Remote: Fully Onsite
Work Schedule: Other
Estimated Salary: ₹25 – ₹35 LPA (based on senior regulatory roles in the Indian MedTech/IVD sector)
About the Role:
Thermo Fisher Scientific is seeking a Regulatory Affairs Manager to oversee premarket approvals and post-market vigilance for In-Vitro Diagnostic (IVD) and Medical Devices within South Asia. This role requires regulatory expertise, strategic leadership, and cross-functional collaboration to ensure timely product approvals and ongoing compliance with local and regional regulatory requirements—especially with CDSCO in India.
Key Responsibilities:
Lead and execute regulatory submissions for IVD/Medical Devices in the South Asia market, ensuring timely approvals and quality standards
Ensure compliance with QMS/GMP standards at the Thermo Fisher India facility
Collaborate with R&D, QA, operations, and product management teams to meet regulatory demands
Conduct strategic regulatory investigations and risk analyses
Prepare, maintain, and update technical files/dossiers for global product registrations
Lead clinical studies, performance evaluations, and testing for local registrations
Coordinate and resolve technical complaints through effective post-market surveillance strategies
Provide input on advertisement material reviews for compliance with regional MD/IVD regulations
Monitor and analyze regulatory changes, offering impact assessments to project teams
Represent the company at regulatory audits, exhibitions, and industry conferences
Build and maintain professional relationships with CDSCO, policymakers, and consultants
Required Qualifications:
Bachelor’s or Master’s degree in Engineering, Sciences, or Medicine
10+ years of regulatory affairs experience in Medical Devices and/or IVD, specifically with Indian CDSCO regulations
Key Skills & Abilities:
Expert-level knowledge of CDSCO and South Asian regulatory environments
Proficient in regulatory strategy, submissions, and dossier preparation
Strong communication and presentation skills
Skilled in cross-functional collaboration and stakeholder alignment
Leadership experience in compliance activities and regulatory audits
Highly organized, analytical, and proactive in solving regulatory challenges
Comfortable navigating regulatory ambiguity and leading through change
Ability to multitask and manage dynamic priorities under tight timelines
Why Thermo Fisher Scientific?
Work with a global life sciences leader improving millions of lives worldwide
Be part of a quality-first culture focused on precision, compliance, and innovation
Access robust career development programs, benefits, and industry recognition
Join a company committed to integrity, intensity, involvement, and innovation
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