Supervisor, Regulatory Affairs

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Description

This role is responsible for leading the regulatory market access team driving complex global regulatory submissions for IVD and Medical Device portfolios. This role includes defining strategic regulatory pathways, mentoring junior team members, and partnering with internal and external stakeholders to ensure regulatory compliance and successful market access worldwide.

Responsibilities

• Lead development and execution of global regulatory strategies for product registrations, renewals, and change controls across major markets.

• Prepare, review, and submit regulatory dossiers under MDR, IVDR, and other regional frameworks (APAC, LATAM, EMEA etc.).

• Manage end-to-end submission lifecycle including gap analysis, remediation, application tracking, and response coordination.

• Partner closely with R&D, Quality, and Manufacturing teams to ensure regulatory input into design and development documentation.

• Coordinate directly with Notified Bodies and health authorities to resolve queries and facilitate timely approvals.

• Maintain and update regulatory documentation and databases for global portfolio maintenance.