Regulatory Affairs Specialist – Bratislava, Slovakia

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).
⦁ 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.

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.

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 Bratislava, Slovakia.

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