Base: $78,000.00 – $156,000.00; bonus/equity: not ...
Not specified (assumed hybrid)
Clinical evaluation report management
Meddev 2.7/1 rev 4 knowledge
Eu regulation 2017/745 expertise
Abbott is seeking a Senior Project Manager for Clinical Evaluation in Maple Grove, Minnesota, to oversee regulatory submissions related to medical devices, particularly in the structural heart sector. The ideal candidate will possess significant expertise in clinical evaluation processes, regulatory guidelines, and project management, particularly in the medical device industry
Job Summary
The role involves managing the development of Clinical Evaluation Reports to support CE Marking for new and existing medical devices in accordance with European Commission Guidelines.
This position requires oversight of medical writers and cross-functional collaboration to ensure safety, performance, and risk/benefit profiles are accurately documented for regulatory submissions.
Candidates must interpret clinical data, lead responses to Notified Body questions, and contribute to product development lifecycle evaluations within a global healthcare leader.
Matching Summary
Match Score: 75
Abbott is seeking a Senior Project Manager for Clinical Evaluation in Maple Grove, Minnesota, to oversee regulatory submissions related to medical devices, particularly in the structural heart sector. The ideal candidate will possess significant expertise in clinical evaluation processes, regulatory guidelines, and project management, particularly in the medical device industry.
Salary
Base: $78,000.00 – $156,000.00; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Clinical Evaluation Report management
MEDDEV 2.7/1 Rev 4 knowledge
EU Regulation 2017/745 expertise
Medical device regulatory submissions
Cross-functional team leadership
Nice-to-have
Structural heart device experience
Strong written communication skills
Strategic regulatory guidance ability
Root cause analysis participation
Audit response facilitation
Key Requirements
Bachelor's degree in science or medical field
3-4 years experience in regulated industry
Experience writing CERs per MEDDEV 2.7/1 Rev 4
Understanding of MDR 2017/745 and ISO standards
Project management and people management experience