Associate Director, Regulatory Affairs - In Vitro Diagnostics and Digital Health
Core
Lead regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology across development, submissions, and commercialization.
Role type
Senior Device Regulatory Affairs Lead (Diagnostics Focus)
Builds
Regulatory pathways and commercialization plans for device and diagnostics programs
Domain
Life Sciences / Medical Devices / Diagnostics
Required skills
Medical Device/In Vitro Diagnostics regulatory affairs, U.S. medical device submissions (IDE, 510(k), PMA), international regulations (MDR/IVDR, PMDA), Companion Diagnostics regulations, project management, stakeholder collaboration
Preferred skills
Advanced degree in scientific discipline
Technologies
None stated
Responsibilities
Support device regulatory strategies across development, submissions, and commercialization; Coordinate regulatory pathways, development timelines, and commercialization plans; Lead health authority meetings covering In Vitro Diagnostics and Digital Health Technology; Present regulatory positions during agency interactions; Communicate critical program updates and regulatory risks to senior management; Build relationships with internal stakeholders and external device development partners; Monitor emerging technologies and global regulations impacting diagnostics and digital health
Seniority
Senior, hands-on IC