Analytik NEWS
Online Laboratory Magazine
07/25/2024

Senior Regulatory Affairs Manager (m/f/d)

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Your Profile:

  • ou have a degree in natural sciences, technology, engineering, medicine or a comparable degree or have acquired a comparable qualification
  • You have several years of relevant professional experience in the field of medical device regulation
  • You have extensive knowledge of regulatory affairs with a focus on international product approvals
  • You have in-depth knowledge of European and international medical device regulations, directives and standards
  • For communication in our international team your good skills in written and spoken German and English are required
  • Collaboration with cross-functional teams to collect necessary information is a daily mission for you
  • You are enthusiastic about mastering challenges in a team and show the necessary stamina when things get difficult.
  • You have a positive attitude and communicate in an open and direct manner
  • You impress with your performance and achieve outstanding results
  • You interact constructively, take responsibility and share your knowledge actively

Your Tasks:

  • You will prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations
  • The area of your responsibility comprises successful approval of medical devices (Class III) in the European and US market (MDR and FDA)
  • You will monitor new legislations, policies, standards and guidelines that affect the assigned product portfolio.
  • You will conduct post-market surveillance and report adverse events/field safety corrective actions to the authorities
  • In your role you will be supporting currently marketed products, e.g, review engineering changes, product labeling and promotional materials


» Job description


Employer:
B. Braun New Ventures GmbH
Location:
79110 Freiburg
Temporary:
No
Type:
Full-time