Regulatory Affairs Specialist - Medical Devices (m/f)

Regulatory Affairs Specialist - Medical Devices (m/f)

Job Title: Regulatory Affairs Specialist - Medical Devices (m/f)
Contract Type: Permanent
Location: München (81249), Bayern
Salary: Negotiable
Start Date: ASAP
Reference: DP 160890_1523613380
Contact Name: Daniel Perkins
Contact Email:
Job Published: April 13, 2018 10:56

Job Description

Regulatory Affairs - Medical Devices m/f


My client located in the Munich area are a pioneer within the Medical Device industry with over 100 years operating in their area of the market. You will have the chance to join a dynamic, motivated group of professionals who all share the same goal to continue the well-established success of the company.

The role:

  • Independent and timely creation of registration dossiers for the global approval of the company's medical devices as well as archiving the registration documentation
  • The monitoring of existing registrations for timely initiation of re-registration and notification of changes in products on an international basis
  • Preparation and evaluation of global registration requirements for internal interfaces and external partners
  • Termination of marketing in relation to specific products and countries
  • Process responsibility for the item country approval
  • Constant updating and archiving of product documentation
  • Preparation and updating of the declaration of conformity

Your profile:

  • Completed relevant studies In Life Science related fields or equivalent qualifications
  • You have previously worked in Regulatory Affairs for Medical Devices and previously performed registrations for Medical Devices (preferably on an international scale)
  • Knowledge of international approvals with external partners outside of EU
  • FDA approval experience would be a great bonus
  • Fluency in English and German both written and spoken