Principal Regulatory Affairs Specialist Vascular
Overview
Lead regulatory affairs specialist for Abbott Vascular on-site in St. Paul MN. Provide support for regulatory department ensuring efficient compliant business processes. Perform specialized level work assignments and analyze documentation for worldwide regulatory registration. Assist in identifying data needed and presenting it for product market entry.
What You'll Do5
- 1Develop worldwide strategies for regulatory approval of new and modified products
- 2Prepare robust regulatory applications for FDA and international agencies
- 3Coordinate regulatory submissions including IDE European Dossiers PMA Supplements Change Notifications
- 4Represent Regulatory Affairs on cross-functional product development and manufacturing support teams
- 5Maintain annual licenses registrations and post-marketing compliance
Requirements5
- 1Bachelor’s Degree in Scientific discipline
- 2Experience in regulatory submissions for pharmaceutical in vitro diagnostic medical devices
- 3Regulatory Affairs Certification (RAC) preferred
- 4Familiarity with 21 CFR 820 ISO 13485 Medical Devices Directive
- 5Ability to work in matrixed diverse environment
Salary Insight
Salary not disclosed in listing
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