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Regulatory Affairs Specialist

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Regulatory Affairs
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21000982 Requisition #

Regulatory Affairs Specialist

Careers that Change Lives

Are you a professional in Regulatory Affairs with proven experience and knowledge in the Medical Devices industry in Serbia? We want to hear from you!

As a leader in the field, 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.


A Day in the Life
We are currently looking for a responsible for Regulatory Affairs Specialist in Serbia. In this position you will ensure that all regulatory and quality requirements necessary to obtain timely regulatory approvals (e.g commercial medical devices) within country are met and quality questions for any Medtronic distributed product and properly addressed.

We offer you a position where you will need to:
•    Understand the regulatory and quality environment within Serbian market,
•    Assess incoming regulatory and quality information and enter the appropriate data into systems and the internal corporate databases,
•    Interact with all areas of regulatory affairs and quality to ensure information is current, accurate and available in the appropriate systems,
•    Preparation of the appropriate and necessary internal SOPs and guidance documents,
•    Act as a resource for support of Regulatory, local BU, external stakeholders (distributors),
•    Coordinates the execution of Field Corrective Actions, 
•    Coordinates translation of product labeling (IFU and Label) if applicable,
•    Maintain, track and evaluate the main suppliers of the organization (distributors, translation agencies, etc.) in the field of the quality.
 

Must Haves
•    Bachelor or Master degree iin a related field
•    At least 3 years of Regulatory experience within medical devices
•    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
•    Proficiency in Serbian and English language.

Nice to Haves
• Experience with device safety reporting
• Experience in Quality Systems
• Work experience working with distributors
• Work experience within large enterprises

Your Answer 
Is this the position you were waiting for? Then please apply directly via the apply button! 


About Medtronic
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.
 

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