Regulatory Affairs Specialist - Risk Management in Jena

Occlutech GmbH veröffentlicht

Stellenbeschreibung

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.

Voraussetzungen

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.

Jetzt bewerben

Regulatory Affairs Specialist - Risk Management

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Occlutech GmbH Occlutech GmbH

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Mehr zum Job

Anzeigenart Stellenangebot
Arbeitszeit Vollzeit
Vertragsart Festanstellung
Berufliche Praxis mit Berufserfahrung
Aus- und Weiterbildung Abschluss Hochschule / Berufsakademie / Duales Studium
Berufskategorie Technische Berufe, Ingenieurwesen / Qualitätsicherung, Qualitätsprüfung
Arbeitsort Winzerlaer Str. 2, 07745 Jena

Arbeitgeber

Occlutech GmbH

Kontakt für Bewerbung

Frau Mag. Monika Tschoner

Mehr zum Arbeitgeber

Benefits
Occlutech GmbH
Regulatory Affairs Specialist - Risk Management
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