Senior RA Specialist

Salary/Rate:60,000EUR - 70,000EUR
Job type:Perm
Business Sectors:Regulatory Affairs
Job ref:24686
Post Date:19. 01. 2024

About the Role

Senior Regulatory Affairs Specialist


Would you like to work for a global healthcare leader in point of care diagnostics? 

We are currently supporting our client who is looking for a Senior Regulatory Affairs Specialist to join their Diagnostics Division in Jena, Germany.

Your tasks:
  • Preparing and submitting technical files and communications to the Notified Body and regulatory agencies
  • Supporting the regulatory department for efficient and compliant business processes
  • Contributing to process/product improvement projects and risk management
  • Assisting with label development and review for compliance
  • Building strong relationships with internal and external stakeholders

Your profile:
  • Bachelor’s degree (BA/BS) from an accredited University
  • Minimum of 2 years experience working in Regulatory Affairs with medical devices (e.g. with MDR or IVDR)
  • Strong communication skills in English and German
  • Strong attention to detail and a positive, flexible mindset
  • Team player, preferably with experience in project- and team management
Basic understanding of IVD regulation and experience generating quality documentation is a plus!

  • Meaningful Impact: contribute to improving patient well-being
  • Career Growth: international opportunities in a fast-growing industry
  • Attractive Benefits: comprehensive package including pension and stock options
  • Global Recognition: join a globally recognized, diverse, and inclusive workplace
  • Collaborative Environment: work with a dynamic, skilled team in an open and efficient culture
If you feel this role was made for you, apply with your CV or contact Vivien Urban for further details or additional vacancies in the MedTech industry.

No CV? No problem - you can leverage your LinkedIn profile instead.