Thermo Fisher Scientific Hiring: Regulatory Affairs Lead – Global Market Access
Thermo Fisher Scientific is hiring an experienced Regulatory Affairs Lead – Global Market Access to support its global In Vitro Diagnostics (IVD) and Medical Device portfolio. This leadership role offers the opportunity to drive complex international regulatory submissions, develop global regulatory strategies, and collaborate with cross-functional teams to ensure successful product approvals across worldwide markets.
As part of Thermo Fisher Scientific, you'll contribute to advancing healthcare innovation while helping deliver solutions that make the world healthier, cleaner, and safer.
Position
Regulatory Affairs Lead – Global Market Access
Work Schedule
Standard (Monday–Friday)
Work Environment
Office-Based
Key Responsibilities
Lead the development and execution of global regulatory strategies for product registrations, renewals, and change controls.
Prepare, review, and submit regulatory dossiers under MDR, IVDR, FDA 510(k), PMA, and other regional regulatory frameworks.
Manage the complete regulatory submission lifecycle, including gap analysis, remediation, application tracking, and authority responses.
Collaborate with Research & Development, Quality, and Manufacturing teams throughout product development.
Coordinate directly with Notified Bodies and global health authorities to facilitate timely product approvals.
Maintain regulatory documentation, submission databases, and product registration records.
Provide regulatory guidance to regional teams across APAC, LATAM, EMEA, and other global markets.
Support product labeling reviews, change assessments, and post-market regulatory compliance.
Identify opportunities to improve regulatory submission processes and documentation workflows.
Mentor and manage regulatory specialists while ensuring high-quality project delivery.
Ensure regulatory documentation complies with applicable global standards and company procedures.
Education & Experience
Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or a related field.
Advanced degree is preferred.
Minimum 12+ years of experience in Global Regulatory Affairs for IVDs and Medical Devices.
Hands-on experience with global regulatory submissions and health authority interactions.
Previous leadership or team management experience is preferred.
Required Skills
Strong knowledge of MDR, IVDR, FDA 510(k), PMA, and global medical device registration pathways.
Experience managing multiple regulatory submissions across international markets.
Excellent technical writing and regulatory documentation skills.
Strong analytical, problem-solving, and project management abilities.
Effective cross-functional collaboration and stakeholder management skills.
Experience with digital regulatory submission platforms and document control systems.
Ability to balance strategic planning with day-to-day regulatory operations.
Salary Package
Estimated CTC: ₹40–70 LPA (Not officially disclosed by the company. Estimated based on similar Global Regulatory Affairs Lead positions, experience, location, and interview performance.)
Why Join Thermo Fisher Scientific?
Work with one of the world's leading life sciences and healthcare organizations.
Lead global regulatory projects across multiple international markets.
Collaborate with global experts in Regulatory Affairs, R&D, Quality, and Manufacturing.
Gain exposure to complex international regulatory frameworks and product approvals.
Access excellent career growth, leadership development, and learning opportunities.
Contribute to innovative healthcare solutions that improve lives worldwide.
How to Apply
Interested candidates can apply through the official Thermo Fisher Scientific Careers portal by searching for the Regulatory Affairs Lead – Global Market Access position and submitting their updated application online.
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