Mary A. Mayka

Associate Director, Regulatory Affairs at Abbott

Role
Associate Director, Regulatory Affairs at Abbott
Location
Minneapolis, MN, US
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

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

  1. Associate Director, Regulatory Affairs

    Abbott

    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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Mary A. Mayka — Associate Director, Regulatory Affairs at Abbott in Minneapolis, MN, US | Unifers