Thomas Geiser
- Role
- Regulatory Affairs Specialist at Stryker
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Thomas Geiser
Strategic regulatory specialist with experience in regulatory affairs, EUMDR…
Experience
Regulatory Affairs Specialist
Aug 2022 — Present
Scope of work - MDD to MDR implementation and EUMDR submissions - Creation of EUMDR Technical Document Files for Class I, II and devices - EU and US Regulatory assessments on change orders and supplier change notifications - FDA PMA and 510(k) submissions encompassing PMA submissions, annual reportable, 30-day notices, 90-day real-time reviews, and PMA supplements- Strategic planning and regulatory support - New product development planning, strategy, regulatory support, and creation of FDA and EUMDR submissions.
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