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.
Andra Pradesh :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
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Wavre |BULGARIA :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
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Hangzhou |Melbourne :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
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Sofia |Canada :
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Croatia |Zagreb :
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Lyon | Paris |Attica :
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Bucharest |Makkah :
Khulais | Rabigh | King Abdullah Economic City | Jeddah | Najran | Riyadh |Nišava District :
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Taipei |Williamson :
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