Senior Regulatory Affairs Specialist
Core
Prepare regulatory submissions for new and modified medical devices and in vitro diagnostic devices to secure market clearance/approval in domestic and international markets.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory submissions (510(k), PMA, supplements, IDEs) and product release documents for medical devices and IVDs
Domain
Medical Devices / In Vitro Diagnostics / Regulatory Compliance
Required skills
U.S. medical device regulatory requirements, EU Medical Device and IVD Directive requirements, Good Laboratory Practices (GLP), Quality System Regulations (QSR), risk assessment, project management
Preferred skills
Biological sciences, chemistry, or related science degree (via careerplan.io/jobs/6207281004-senior-regulatory-affairs-specialist-at-natera)
Technologies
None stated
Responsibilities
Develop strategies for submissions to FDA and other regulatory agencies; Prepare U.S. regulatory submissions (510(k)s, PMAs, supplements, PDPs, IDEs); Coordinate preparation of data/information requested by regulatory agencies; Review clinical protocols and study data; Review labels, labeling, and promotional materials for compliance; Provide regulatory opinions on premarket, export, and labeling requirements
Seniority
Senior, hands-on IC