Regulatory Affairs Supervisor / Супервайзер з питань регуляторної політики

About Medtronic
Bold thinking. Bolder actions. We are Medtronic.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.
In everything we do, we are engineering the extraordinary.

A Day in the Life

•Develop and execute Regulatory Strategy for CEE Cluster East countries in cooperation with local Operating Unit and Marketing Teams
•Keep abreast of regulatory regulation and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements
•Cooperate with local Competent Authorities and other external stakeholders
•Collect all materials required in submissions, license renewal and annual registrations
•Oversee the execution and timeliness of Vigilance and Field Corrective Action processes in the countries
•Lead and develop the Team of Regulatory Affairs Talents  

Must Haves

•Bachelor’s degree with 4+ years of experience
•Regulatory experience in Medical Devices and or Pharmaceuticals is required
•Understanding of medical device regulations and standards
•Fluent spoken and written English and Ukrainian
•Excellent written and verbal communication skills
•Strong teamworking skills with a strong drive to succeed

Nice to Haves

•Working knowledge of The European Union Medical Device Regulation
•Ability to flex and adapt to changing priorities
•Strong interpersonal and organizational skills
•Managerial experience will be an asset

Careers that Change Lives
Change your career to exploration, innovation, and championing healthcare access and equity for all. Join a healthcare technology company that alleviates pain, restores health, and extends life for more than two people every second.
As a Regulatory Affairs Supervisor, you will be responsible for developing strategies and executing on regulatory submissions to introduce new products and therapies and maintain existing products to CEE (Central and Eastern Europe) Cluster East countries, while leading a team of Regulatory professionals.

We Offer
We offer a competitive salary and benefits package to all our employees:


•Flexible working environment
•Annual Incentive Plan % depending on company results
•Pension scheme and group discount on healthcare insurance
•Training possibilities via Cornerstone/Harvard Manage Monitor/Skills Lab
•Employee Assistance Program and Recognize! (our global recognition program)

Your Answer
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