Alyssa Skarhorst Email & Phone Number

Saint Paul, Mn, Us

- Submitted regulatory submissions for Class IIb initial registrations, device design change registrations, and license renewals. Submissions of note are in China, South Korea, Brazil, and South Africa.-Assisted in 510(k) submission preparation and review- Collaborated cross-functionally with Operations Engineering, Marketing, and Program Management for device design changes, market expansions, end of life activities, and prospective market regulatory analysis- Provided regulatory support for Quality Engineering, Customer Service, and Supply Chains efforts to use alternative systems or consumables if there is a stock shortage or market inclusion request- Reviewed and updated labeling changes and user manual changes based on new or changing regulatory requirements

- Completed Class IIa international initial registrations in APAC, LATAM, and EMEA.Wrote and revised technical documentation for Class I nonsterile and sterile, Class IIa medical devices- Wrote and revised Clinical Evaluation Plans and Reports for Class I nonsterile medical devices - Reviewed and fulfilled medical device regulatory requirements for international markets - Reviewed and approved marketing material, product updates, labeling changes, and NCMR disposition plans for regulatory impact (Change Management)

- Worked with international and domestic regulatory colleagues to appropriately report and review new final or proposed global requirements to support timely international submissions and approvals.

Greater Minneapolis-St. Paul Area

- Conducted Restorative Therapy Group (RTG) Medtronic clinical studies that alleviate patient pain - Analyzed and presented results of clinical investigations as trending responsible for quality metrics - Oversaw and resolved operational aspects of clinical studies in conjunction with project teams in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.

- Reviewed subject potential complaints in Structural Heart device implant and follow-up information in daily reports/Oracle Clinical to ensure potential complaints are sent within compliance deadlines- Reviewed source documentation from clinical study sites and reported any unreported adverse events- Reviewed and adjudicated adverse event medical information to determine if event meets specific endpoints requiring Clinical Events Committee adjudication

Greater Minneapolis-St. Paul Area

- Co-conducted clinical trial safety review meetings (CEC meetings) - Assisted in reviewing draft study safety plans, routed for approval in Documentum QMS system

Master'S Degree

Bachelor Of Arts - Ba