Aimee Tardif
- Role
- Senior Regulatory Affairs Specialist at Medtronic
- Location
- Fort Collins, CO, US
- LinkedIn followers
- 500 followers
About Aimee Tardif
Project Lead, Regulatory Affairs Specialist, and Technical Writer with 7+ years…
Experience
Senior Regulatory Affairs Specialist
Jul 2023 — Present
Leads regulatory guidance for digital health products for the development of insulin delivery systems for patients living with Type 1 and intensive Type 2 diabetes. • Authors post-approval reports and annual reports supporting post-market regulatory compliance activities. • Peer reviews submissions and evaluates proposed product changes for regulatory impact. • Authors and supports the development of MAF, 510(k), PMA-S (30-day notices), and PMA submissions. • Leads and develops training for a department-wide regulatory writing improvement initiative. • Utilizes content management system to track deliverables and submission tasks generating status reports to be shared with senior leadership. • Reviews and approves design reviews, labeling, and other deliverables for product development for regulatory compliance.
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