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About the Role We are seeking an experienced Regulatory Affairs professional specializing on in vitro diagnostics (IVD) and Companion Diagnostics (CDx) to join our Global Regulatory Affairs team.
In this strategic role, you will provide expert guidance on regulatory pathways for IVD and CDx development, clinical trials, and marketing authorizations while collaborating with cross-functional teams and external partners.
The role can be office or home based in various European locations.
Key Responsibilities Develop and align global regulatory strategies for companion diagnostics across clinical trials, marketing authorizations, and lifecycle management.
Collaborate with IVD and CDx partners and Clinical Measurement Sciences (CMS) teams to integrate regulatory considerations into IVD and CDx development plans.
Ensure alignment between global and regional IVD and CDx regulatory strategies, involving local GRA teams as needed.
Draft and review IVD and CDx-related content for drug/device regulatory submissions.
Lead or support regulatory agency interactions, including document preparation and meeting coordination.
Manage IVD and CDx-specific submissions (e.g., Performance Study Applications in the EU) and responses to agency queries.
Provide comprehensive regulatory risk assessments and communicate risks to internal stakeholders.
Serve as a subject matter expert on Global Project Team Regulatory Sub-teams.
Support IVD / CDx partner selection processes, due diligence activities, and contracting.
Offer specialized regulatory consultation on IVD and CDx.
Participate in cross-functional and GRA initiatives to advance organizational objectives.
Skills and Experience required for the role: University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.
Minimum 5+ years of experience in Medical Device/IVD regulatory affairs Extensive knowledge of international regulations for Medical Devices/IVD, with particular expertise in US and EU regulatory frameworks.
Demonstrated experience with in vitro diagnostics and companion diagnostics regulatory pathways and regulatory submissions.
Strong understanding of the drug-diagnostic co-development model.
Experience working with regulatory agencies on IVD and CDx matters.
Fluent in English, written and spoken.
Experience also in medical devices and/or combination products would be a plus.
Proficiency with regulatory systems including Veeva and TrackWise would be a plus.