Regulatory Affairs Specialist (focuse on Baltics)

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future.Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

A Day in the Life

We are currently looking for a responsible for Regulatory Affairs in Baltics (Latvia, Lithuania, Estonia) based in Kiev, Ukraine. In this position, you will ensure that all local regulatory requirements are met and quality questions for any Medtronic distributed product and properly addressed.

Responsibilities:

• Understand the regulatory environment within markets
• Assess incoming regulatory information and enter the appropriate data into systems and the internal corporate databases
• Build up, maintain and follow up contacts with the necessary competent Authorities
• Interact with all areas of regulatory affairs and quality to ensure information is current, accurate and available in the appropriate systems
• Act as a Regulatory Affairs resource for support local sales and marketing team, external stakeholders (distributors), etc.
• Coordinates the execution of Field Corrective Actions

Must Haves

•  Bachelor or Master degree in a related field

•    Proven track record of relevant regulatory and quality environment in medical devices

•    Proven track record of experience working with complex databases

•    General knowledge of GDP (good document practice)

•    Proficiency in English

•    Understanding of EU Regulations   MDR Medical Devices Regulation

Nice to haves

•    Experience with device safety reporting

•    Knowledge in one of Baltics language

•    Experience in Quality Systems

•    Work experience working with distributors

•    Work experience within large enterprises

Careers that Change Lives

Are you a Regulatory specialist with a proven history of success? Do you enjoy a challenge?

If you like this, why not consider working for Medtronic as a Regulatory Affairs and Quality Specialist!

Medtronic is working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us and be part of our commitment to the health of others.

For this role you need to be located in Kiev.

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