Job offers

The sister companies Medipan GmbH and GA Generic Assays GmbH are leading providers of laboratory diagnostics and automation in the field of immune diseases. We develop, produce and distribute a broad product portfolio of immunoassays and laboratory instruments for research and routine diagnostics worldwide.

To strengthen our QM team we are looking for an experienced

Regulatory Affairs Manager (m/f/d)

Your new position

  • • Communication with our international partners
  • • Preparation and maintenance of regulatory documents
  • • Identification of regulatory requirements (research laws, regulations, guidelines, standards)
  • • Verification of the implementation of corresponding regulatory requirements (verify existence
  •   and quality of regulatory documents)
  • • Communication and cooperation with external entities that check the implementation of
  •   regulatory requirements regulatory requirements (authorities, notified bodies)
  • • Creation of procedures for various processes (e.g. quality management, risk management,
  •   vigilance, post-market surveillance, product management, etc.)
  • • Evaluation and assessment of laboratory results, clinical data as well as publications
  • • Perform and support internal and external audits

What you bring with you

  • • Completed university studies (Bachelor / Master) or training as a BTA, CTA, CBTA or a
  •   comparable degree with many years of experience in the field of regulatory affairs
  • • Basic knowledge of the regulations for in vitro diagnostics (IVDR)
  • • Very good knowledge of German and English, both written and spoken
  • • Ability to work in a team and enjoy the task
  • • Very good communication skills
  • • Laboratory experience is an advantage

What you can expect

  • • A globally active employer with great challenges
  • • A permanent position and thus a predictable future
  • • Collaboration in an innovative, growing family business that has been in existence for over
  •   thirty years
  • • Varied tasks with a lot of personal responsibility
  • • Full-time position with 40 h/week
  • • No shift work or weekend work
  • • Flexible working time model
  • • Cooperation in a multicultural and collegial working environment
  • • Deutschlandticket-Job
  • • Free charging facility for electric vehicles
  • • Employer participation in company pension plan
  • • Individual further training opportunities
  • • High degree of individual development opportunities

Do you want to master new challenges with us?
If we have aroused your interest and enthusiasm, we look forward to getting to know you. If possible, please send us your application with a complete file (in PDF) and the complete application documents (cover letter/resume/credentials) as well as your desired salary and availability by e-mail or by post.

Our companies follow the legal provisions of the Equal Treatment Act (AGG) and SGB IX. All attributes in this offer refer to both female, male and diverse persons.

Starting date:   as soon as possible
Contract duration:   unlimited
Type of position:   full-time

Place of work
Medipan GmbH / GA Generic Assays GmbH
Ludwig-Erhard-Ring 3
15827 Blankenfelde-Mahlow OT Dahlewitz

Your personal contact
Kai Reiser (Authorized signatory)
Phone: +49 33708 4417 23
E-mail: k.reiser@medipan.de