• Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area.
• Support International Product Registrations to integrate newly acquired IVD medical devices for the Business Area.
• 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
• 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.
If you have the above qualification and are available to look into this opportunity please send your updated resume along with your contact# and I will call you back to discuss further.
APN Software Services, Inc .
39899 Balentine Drive, Suite 385, Newark, CA 94560 .
Direct: 510.623.5049 | Fax: 510.623.5055 | Email: firstname.lastname@example.org