Senior Manager, Regulatory Affairs
Core
Leads ex-US regulatory strategy for NGS-based in vitro diagnostic (IVD) products and companion diagnostics, focusing on EU IVDR and Health Canada while managing biopharma co-development partnerships.
Role type
Senior Manager, Regulatory Affairs (Strategy & Leadership)
Builds
Global regulatory roadmaps, technical files, and submission strategies for NGS IVDs and CDx programs.
Domain
Life Sciences / Molecular Diagnostics / Regulatory Affairs
Required skills
EU IVDR technical documentation, Health Canada Medical Device License applications, global regulatory strategy, biopharma companion diagnostic co-development, FDA IVD pathways (510k/De Novo/PMA), ISO 13485/14971, Notified Body engagement, team mentorship
Preferred skills
Clinical trial regulatory experience, additional international market frameworks (UKCA/TGA/NMPA), genomic data privacy (GDPR)
Technologies
NGS assays, medical device software frameworks
Responsibilities
Own and evolve ex-US regulatory strategy; lead negotiations with international authorities and Notified Bodies; serve as regulatory lead for biopharma co-development; mentor junior regulatory staff; align global submission content and labeling; contribute to departmental budgeting and SOP development.
Seniority
Senior Manager, hands-on leadership
