Baden Württemberg: Regulatory Affairs Manager (m/f/d) Medical Device

Tübingen, BW, DE, Germany

Job Description

Our client develops, manufactures and distributes cutting-edge surgical technology worldwide.

At its location close to TÜBINGEN, we are currently recruiting for a: REGULATORY AFFAIRS MANAGER (m/f/d)



Homeoffice:

50%

Details:

permanent position – 35 hrs. per week – 35 vacation days per year



Aufgaben



Preparation and updating of technical documentation for medical devices in compliance with MDR 2017/745 Ensuring compliance with applicable regulatory requirements Development of test plans, organization of testing procedures, and definition of test characteristics and equipment Creation of standard test reports to demonstrate compliance with relevant norms Acting as the main contact for notified bodies during technical documentation reviews and regulatory inquiries from development and production teams Defining regulatory strategies for the approval of medical devices

Qualifikation



A completed degree in engineering or natural sciences Professional experience in Regulatory Affairs for medical devices Knowledge in the areas of ISO 13485 and MDR Excellent German (C1) and English language skills, both written and spoken Strong coordination and organizational skills

Benefits



What TRIGA Offers You:



New career perspectives and comprehensive consulting for your personal RA career Positions that match your skills, knowledge, and goals Exclusive job opportunities with background information about the company Optimization of your application documents and intensive preparation for interviews Direct access to decision-makers and negotiation of the best compensation package

YOUR CONTACT:



Silvio Di Meglio

Managing Director at TRIGA Consulting GmbH & Co. KG

089-8091307-21

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Job Detail

  • Job Id
    JD3643991
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Tübingen, BW, DE, Germany
  • Education
    Not mentioned