Staff Regulatory Affairs Specialist
Core
Maintain market access for PreAnalytiX and Lab Specimen Management product portfolios and provide regulatory support for new product development in the US and EU.
Role type
Staff Regulatory Affairs Specialist (Medical Devices/IVD)
Builds
PreAnalytiX and Lab Specimen Management medical devices and in vitro diagnostics
Domain
Medical Technology / In Vitro Diagnostics
Required skills
Regulatory strategy development, 510(k) submission preparation, CE marking coordination, risk assessment, change control management, technical writing, FDA liaison, international regulatory compliance (MDR/IVDR), product labeling review
Preferred skills
Advanced degree, experience with Safer Technologies Program (STeP), Breakthrough Device designation, Predetermined Change Control Plans (PCCPs), STED familiarity, negotiating with regulatory authorities
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Coordinate and prepare premarket applications to the US FDA (510(k), Pre-Sub, De Novo); Assess necessity for 510(k) submissions and prepare non-filing justifications; Coordinate technical files for European Notified Bodies; Represent RA in cross-functional teams to interpret regulatory requirements; Identify and communicate quantified risks; Manage Notification of Change (NOC) assessments; Develop regulatory strategies for Change Controls; Lead efforts to follow new regulations (EU MDR/IVDR, MDSAP); Review and approve product labeling and promotional materials; Ensure FDA device listings are maintained; Develop and maintain SOPs; Represent BD in external trade organizations
Seniority
Staff, hands-on IC with leadership responsibilities