Regulatory Affairs Manager

Thermo Fisher Scientific

10 years years

not specified

Bangalore

10 Sept. 5, 2025

Job Description

Job Type: Full Time Education: Bachelor’s degree or higher in Engineering, Life Sciences, or Medicine. 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 Type: Full-time
🏢 Work Environment: Fully Onsite
🔢 Job ID: R-01321070
📁 Category: Quality & Regulatory
📆 Work Schedule: Other
🌿 Environmental Conditions: Office

About Thermo Fisher Scientific – The Quality Difference

At Thermo Fisher Scientific, our Quality teams are united by a passion for doing things right the first time—with a customer-centric mindset. As part of our global Quality function, you’ll help ensure our products and services are safe, accurate, and effective—ultimately making a difference in lives around the world.

Joining us means contributing to high-impact global projects while growing your skills and exploring diverse career paths.

Position Overview – Regulatory Affairs Manager

The Regulatory Affairs Manager will oversee both premarket approvals and post-market vigilance for In-Vitro Diagnostic (IVD) and Medical Devices under the Life Sciences Group (LSG) in South Asia. This role will provide regulatory insights to cross-functional teams and ensure ongoing compliance with Indian and international regulatory requirements.

Key Responsibilities

🌐 Regulatory Submissions & Approvals

Prepare and submit regulatory filings for IVD/Medical Devices in South Asia, adhering to required timelines and quality standards.
Lead regulatory submissions for Animal Health products as needed.

🏭 Manufacturing Plant Support

Support regulatory implementation at the Indian LSG plant to ensure compliance with QMS/GMP standards.

🔬 Collaboration & Strategy

Partner with R&D, Operations, QA, and Product Management to meet compliance and regulatory goals.
Conduct regulatory risk assessments and strategic impact analyses.

📁 Documentation & Dossier Management

Develop and maintain technical files and regulatory dossiers to support both local and global registrations.

🧪 Performance Evaluations

Lead local performance evaluations, clinical studies, and laboratory testing in support of product registrations in India.

🔍 Post-Market Surveillance

Manage technical complaints, corrective actions, and regulatory investigations.
Conduct advertisement reviews for compliance with medical device/IVD regulations.

🏛️ Regulatory Intelligence & Stakeholder Engagement

Monitor and analyze regulatory changes, providing impact assessments for LSG projects.
Build strong working relationships with regulatory bodies (e.g., Indian CDSCO), consultants, and policymakers.

📢 Internal & External Representation

Provide scientific and regulatory consultation within the Global and APAC RA teams.
Represent the company at audits, conferences, and industry exhibitions.

Qualifications & Experience

🎓 Education:

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

💼 Experience:

Minimum 10 years of experience in Regulatory Affairs for Medical Devices or IVD devices.
Strong familiarity with Indian CDSCO and South Asian regulatory environments.

Key Skills & Competencies

In-depth knowledge of IVD/Medical Device regulatory frameworks in India and South Asia.
Expertise in regulatory strategy, submission planning, and dossier compilation.
Strong analytical thinking and problem-solving capabilities.
High proficiency in written and verbal communication, including presentations.
Ability to lead cross-functional projects and manage tight deadlines.
Flexible and adaptable to changing regulatory landscapes.
Strong project management and organizational skills.
Comfortable with ambiguity, providing clear direction in uncertain regulatory environments.
Experience in post-market surveillance, complaint handling, and advertisement compliance.

Why Join Thermo Fisher Scientific?

As part of our mission to enable our customers to make the world healthier, cleaner, and safer, you’ll be part of a global network of professionals pushing the boundaries of science. Thermo Fisher fosters an inclusive and innovative workplace where talent grows, impact multiplies, and people thrive.

Ready to Make an Impact?

Join Thermo Fisher Scientific and take your Regulatory Affairs career to the next level.

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Regulatory Affairs Manager

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