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 that improve lives globally. The Regulatory Affairs team works on global-scale projects and ensures regulatory compliance while supporting employee growth and career development.
Work Schedule
Standard office hours (Other)
Fully onsite
Job Summary
The Regulatory Affairs Manager is responsible for pre-market approvals, post-market vigilance, and regulatory compliance of In-Vitro Diagnostic (IVD) and Medical Devices within the South Asia market. This role provides strategic regulatory guidance to cross-functional teams and ensures compliance with Indian CDSCO and other relevant regulations.
Key Responsibilities
Conduct regulatory submissions for IVD and Medical Devices in South Asia, ensuring timelines and compliance.
Support regulatory activities at the LSG Indian plant, ensuring QMS/GMP compliance.
Collaborate with R&D, operations, QA, and product management teams to meet regulatory requirements.
Conduct regulatory investigations, define strategies, and provide updates to cross-functional teams.
Prepare and manage technical files/dossiers supporting global registration applications.
Lead local performance evaluations, clinical studies, and tests for product registration in India.
Support Animal Health regulatory submissions as needed.
Coordinate post-market surveillance, resolve complaints, and implement corrective actions.
Review marketing and advertisement materials for compliance with MD/IVD regulations.
Analyze new and existing regulations, prepare impact assessments for projects.
Provide regulatory and scientific guidance within the Global/APAC LSG Regulatory Affairs organization.
Participate in regulatory/quality audits, exhibitions, and conferences.
Maintain networks with consultants, policymakers, and regulatory agencies such as CDSCO.
Perform additional tasks as assigned by line manager.
Education & Qualifications
Bachelor’s degree or higher in Engineering, Sciences, or Medicine.
10+ years of experience in regulatory affairs for Medical Devices or IVD devices, especially with Indian CDSCO regulations.
Essential Skills & Abilities
Comprehensive knowledge of regulations, standards, and guidelines for IVD and Medical Devices in South Asia.
Skilled in regulatory and strategic analysis, with acute awareness of regulatory changes.
Strong planning, organizational, and project management skills.
Excellent written, verbal, and presentation communication skills.
Strong analytical, proactive, and resourceful problem-solving abilities.
Ability to work under pressure and manage flexible schedules.
Comfortable with ambiguity and providing mentorship in uncertain regulatory environments.
Experience leading compliance activities, including post-market surveillance and advertisement review.
Ability to build and maintain networks with consultants, policymakers, and regulatory agencies.
Cross-functional collaboration to ensure regulatory and compliance requirements are met.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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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Paris | Lyon |South Africa :
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