Job offer

Regulatory Affairs Manager (m/w/o)

Your tasks

  • Planning, coordination and implementation of all activities to obtain and maintain FDA and CE product approvals for active medical devices up to risk class IIb for our customers
  • Coordination, support and review of documentation accompanying development for product approval of active medical devices, also across departmental boundaries
  • Contact for authorities and notified bodies
  • Internal contact for all approval matters
  • Review and assessment of changes to relevant standards for medical technology
  • Organisation of training courses within the company

Your profile

  • Sound expertise in the area of relevant medical technology directives and standards (93/42/EEC, 60601, 13485, 62304, etc.)
  • Several years of experience in the field of international approvals of Class IIb active medical devices in medical technology
  • Desirable experience with FDA de-novo approval and high-risk software in the MDR
  • Scientific studies and a passion for technology
  • Ability to work autonomously and independently
  • Flexibility, initiative, persuasiveness and team-orientation
  • Very good written and spoken German and English, at least level C1

What do we offer?

In addition to performance-based remuneration, we offer:

  • Modern working time models that rconcile family and career
  • Security through a permanent employment contract
  • Demand-oriented development and advancement opportunities
  • Good working atmosphere
  • Flat hierarchy
  • Team-building measures
  • Regular employee appraisals
  • Free company parking
  • Flu vaccinations
  • Fresh fruit and free drinks
  • Anniversary benefits
  • Company parties

Have we piqued your interest?

Then become part of the BYTEC team!

Send your complete application documents stating your earliest possible starting date and your salary expectations either per post or e-mail.

Privacy policy for applications / PDF

Apply here by mail

BYTEC Medizintechnik GmbH
Frau Dipl.-Kff. Claudia Coenen
Hermann-Hollerith-Str. 11
52249 Eschweiler

Apply here via e-mail