Regulatory Affairs Manager

Thermo Fisher Scientific

10+ years

₹18 – ₹30 LPA

Bangalore

10 Aug. 8, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Manager

Location: Bangalore, Karnataka, India
Job ID: R-01321070
Job Type: Full-Time
Category: Quality & Regulatory
Work Mode: Fully Onsite
Work Schedule: Other (flexibility likely required)
Environment: Office-based
Estimated Salary Range: ₹18 – ₹30 LPA (based on similar mid-to-senior RA roles in medical device/IVD sector in India)

About Thermo Fisher Scientific:

Thermo Fisher Scientific is the world leader in serving science, with ~$40 billion in annual revenue and over 100,000 employees globally. The company’s mission is to make the world healthier, cleaner, and safer. With a broad portfolio of life science, healthcare, and diagnostics products and services, it helps customers accelerate research, solve complex analytical challenges, and deliver life-changing therapies.

Position Summary:

As a Regulatory Affairs Manager, you will lead and execute both premarket approvals and post-market regulatory activities for In-Vitro Diagnostic (IVD) and Medical Devices across South Asia—primarily India. The role is central to ensuring product compliance with regulatory standards and collaborating with cross-functional teams to align strategy, execution, and timelines.

Key Responsibilities:

Lead regulatory submissions for IVD/Medical Devices in South Asia, ensuring adherence to timelines and requirements.
Ensure regulatory compliance of products manufactured at the Indian plant, especially in QMS and GMP practices.
Collaborate with R&D, QA, Operations, and Product Management to align on regulatory strategies.
Define strategies for regulatory investigations and present updates to interdisciplinary teams.
Prepare and maintain technical files and dossiers for local and global product registrations.
Coordinate clinical evaluations, performance studies, and product testing as required by Indian regulations.
Support Animal Health product submissions and other distributed regulatory teams.
Manage post-market surveillance, handle complaints, and ensure corrective actions are implemented.
Review marketing and promotional material for compliance with South Asian IVD/MD regulations.
Keep up-to-date with changing regulations, assess their impact, and advise on implementation strategies.
Participate in regulatory audits, exhibitions, and industry events to represent the organization.
Build and maintain relationships with CDSCO and other relevant Indian and regional regulatory bodies.
Advise internal teams on regulatory best practices and represent regulatory affairs in cross-functional discussions.

Qualifications & Skills:

Education:

Bachelor’s or higher degree in Engineering, Life Sciences, or Medicine

Experience:

10+ years of experience in Regulatory Affairs within Medical Devices or IVD, with strong exposure to Indian CDSCO regulations.

Core Competencies:

Deep knowledge of Indian regulatory landscape (CDSCO) and international IVD/Medical Device requirements.
Skilled in regulatory strategy, submissions, dossier preparation, and audits.
Strong planning, prioritization, and project management skills.
Effective communication skills: verbal, written, and presentation.
Experience in cross-functional leadership, including managing compliance with marketing claims and post-market vigilance.
Able to work under pressure, handle regulatory ambiguity, and lead with clear direction.
Strong analytical and problem-solving skills.

Why Join Thermo Fisher Scientific:

Be part of a mission-driven organization committed to scientific and regulatory excellence.
Access to a global support network, cutting-edge tools, and career advancement opportunities.
Culture rooted in Integrity, Intensity, Innovation, and Involvement.
Opportunity to influence the healthcare and diagnostics landscape in South Asia.

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Regulatory Affairs Manager

Job Description

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