Regulatory Affairs Specialist

3 hours ago


Gothenburg, Västra Götaland, Sweden Moveup Consulting AB Full time

XVIVO is a global medical technology company dedicated to extending the life of organs for transplant patients.

Company Overview

XVIVO is in a rapid growth phase, expanding geographically and developing new products. This position offers an opportunity to play a crucial role at the company.

Job Description

We are seeking a Regulatory Affairs Manager to join our team. Key responsibilities include:

  • Handling vigilance/MDR reporting for markets where XVIVO has a presence.
  • Acting as the Regulatory Affairs lead in projects developing new products.
  • Executing Project Regulatory Planning, including fulfilling requests for documentation, information, and data for registration purposes.
  • Maintaining product registrations by ensuring compliance with applicable regulatory requirements.
Required Skills and Qualifications

The ideal candidate will have:

  • A university degree in a relevant field such as Science, Engineering, or Medicine.
  • Professional experience in Regulatory Affairs, with demonstrated knowledge/experience in quality management systems and medical device regulations.
  • A proven track record of handling product registrations and/or submissions with authorities/agencies/partners.
  • Comfortable speaking and writing English at a professional level.
Benefits

XVIVO offers a collaborative and flexible work environment, a passion for continuous improvement and innovation, and opportunities for professional growth.



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