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Regulatory Affairs Specialist, Poland

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Regulatory Affairs
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19000CNE Requisition #

Regulatory Affairs Specialist – Warsaw, Poland.


Careers that Change Lives

 

Would you like to work for a rapidly growing international healthcare company?

 

Do you consider you have the right experience for a Regulatory Affairs Specialist role? If yes, then send us your resume and enter the recruitment process right away!

 

Join Medtronic where we appreciate your talent, experience and passion for your work. You can count on professional and personal development, exciting challenges and a dynamic environment.

 

This is an exciting opportunity where, as a Regulatory Affairs Specialist you will ensure that all regulatory requirements, necessary to obtain timely regulatory approval for any Medtronic distributed product (e.g commercial medical devices and devices for clinical investigational use) within country are met. The person will handle also the Baltic markets.

 

In return, we will provide you with world-class training, development opportunities, and the opportunity to work in a varied and challenging role. Our offer package will include a competitive salary and other great benefits.

 

For this role you will be expected to be located in Warsaw, Poland.


A Day in the Life
 

Principal responsibilities of Regulatory Affairs Specialist: 

  • Obtains timely regulatory approvals to meet business objectives. 
  • Prepares and coordinates regulatory/registration submissions.
  • Ensures that submissions meet relevant external and internal requirements.
  • Ensures documentation used, questions and answers from authorities and approvals are filed in the appropriate systems.
  • When/ where applicable, supports distributors to obtain the necessary regulatory approvals.
  • Be the first contact window to the authority.
  • Deal with regulatory inquiry.
  • Coordinates the execution of Field Corrective Actions.
  • Provides support for vigilance reporting to the regulatory authorities.
  • Coordinates translation of product labeling (IFU and Label) if applicable
  • Maintains internal databases for regulatory compliance (eg Famous and RAD).
  • Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization.
  • Provides support to tender offers in case of necessary regulatory documentation.
Must Haves and Nice to Haves:
 
Must haves: 
  • Msc degree or Bsc degree with relevant experience
  • Proven track record of relevant regulatory environment (min. 2 years)
  • Medical devices RA management experience
  • Experience working with Government officials
  • Proven track record of experience working with complex databases
  • Experience working as a self-starter
  • Compliance oriented
  • Customer and solution focused
  • Able to work independently, self-starter
  • Strong attention to details and quality in all reporting materials
  • Ability to communicate effectively to all levels of organization and customers (including regulators)
  • Speak the local language
  • Proficient in English, both written and spoken
  • Comfortable experience with Database entry and management
  • General knowledge of “good documentation practice”.
  • Willingness to travel (up to 10% in local market). 
Nice to haves: 
  • Experience with device safety reporting
  • Experience in Quality Systems
  • Experience in working with distributors
  • General business skills
  • Presentation skills
  • Project management skills 

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. 

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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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
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