Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area.
• Support International Product Registrations.
• Completes regulatory documentation for CE Marking IVD medical devices (Technical File updates, Declaration of Conformity etc.)
• Requests Certificates to Foreign Governments, Free Sale Certificates.
• Coordinates and tracks notarization and legalization of regulatory documents.
• Notifies countries of product changes and collects registration information for product teams.
• Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
• Completes the review of promotional material and device labeling for regulatory compliance.
Required Knowledge/Skills, Education, and Experience
• Required Bachelor's degree (preferred in life sciences)
• Required industry experience: 2-5 years
• No travel
• Demonstrated attention to detail, able to manage and track multiple requests at once.
Preferred Knowledge/Skills, Education, and Experience
• Prefer experience in medical device industry and with technical design documentation (2 -5 years)
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.