Mary A. Mayka
Associate Director, Regulatory Affairs at Abbott
- Role
- Associate Director, Regulatory Affairs at Abbott
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Mary A. Mayka
Regulatory affairs professional with 15+ years medical device experience and demonstrated proficiency in global regulatory submissions, clinical research and project management. Thorough understanding of global regulatory landscape and a demonstrated record of successful FDA, EU MDR and other international submissions. Highly motivated, detail-oriented, strategic thinker with an exceptional track record of aligning and prioritizing tasks to meet business needs. Specialized in developing compliant strategies in a complex regulatory environment. Consummate advocate for continuous improvement.
Experience
Associate Director, Regulatory Affairs
Apr 2022 — Present · Minneapolis, MN, US
Associate Director of Regulatory Affairs responsible for global strategy and worldwide approvals for Abbott Neuromodulation devices, including FDA & EU (Class Active Implantable). Manage a team of 10+ RA professionals.
Education
University of Illinois Chicago
Ph.D., Bioengineering (Focus in Neural Engineering)
Saint Mary's College
B.S., Biology
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