Senior Specialist, Regulatory Affairs THV
Core
Ensuring compliance with domestic and international regulatory requirements for Transcatheter Heart Valve (THV) devices from design to production.
Role type
Senior Specialist, Regulatory Affairs (Medical Devices)
Builds
Regulatory submission packages (510(k), PMA, CE marking) and technical documentation for THV devices.
Domain
Medical Devices / Cardiovascular / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy planning, submission package preparation, global regulation monitoring, labeling compliance review, conflict resolution between regulatory and development needs
Preferred skills
Scientific degree background, Class II/III device regulatory knowledge, new product development systems knowledge, international regulatory requirements expertise
Technologies
GUDID, IDE, PMA, 510(k), STED, CE marking design dossiers
Responsibilities
Represent regulatory function on product development teams, prepare and oversee global regulatory submission packages, monitor global regulations and assess project impact, review labeling and product documentation for compliance
Seniority
Senior, hands-on IC