Engineer, Scientist as Regulatory Affairs Specialist - Risk Management

Regulatory Affairs Specialist Risk Management

Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at

Location: Jena

Position Description:

Broad Function

The Regulatory Affairs Specialist – Risk Management ensures the compliance of the risk management process according to ISO 14971 and Occlutech’s quality management system and interacts with the international risk management team and other departments like Research & Development and Clinical Research. The RA Specialist – Risk Management maintains, reviews and approves risk management documentation and coordinates technical experts; he/she deploys risk management best practice, standard operating procedures and general guidance for the application of risk management in device development. The RA Specialist – Risk Management disseminates knowledge and awareness of risk management within the Occlutech organization, supports customer complaints and is responsible for the improvement of the risk management.

Your work will focus on

  • Close collaboration with other departments and change management teams to assess risk for Occlutech Products and create / update risk management files.
  • Collaboration with complaints department and medical device safety officer to support life cycle management esp. during post-market life cycle phase.
  • Keeping quality risk management files in alignment with EU MDR, ISO and further applicable regulations.
  • Conducting risk assessments for Occlutech GmbH products and globally in post market lifecycle phase and providing risk reviews.
  • Support for medical device safety officer in risk related reports.

We are looking for a candidate, who has

  • Technical Scientific Degree (minimum bachelor of science)
  • Knowledge in medical device regulations
  • 1- 2 years experience in risk management, preferably in the medical device industry
  • Exceptional knowledge of English
  • Exceptional social and communication skills

If you are

  • a team player who likes challenges
  • a confident user of standard office software
  • excellent in leadership, communication, organization and time management
then we can offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products.

Are you interested?

We look forward to receiving your application (cover letter, CV, references - all documents in one pdf file), your salary expectation and the earliest possible date for start of work to .
Occlutech GmbH
Winzerlaer Str. 2
D-07745 Jena

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Über Occlutech GmbH

Occlutech was founded in Germany in 2003, and has since developed into one of the world´s leading suppliers in the area of structural heart disease with products and projects for; congenital defects, stroke prevention, and heart failure. The company´s products are sold in over 80 countries globally and the total number of implantations is approaching 100.000, setting the highest standards...
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