Connecting...

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9zy2lwcm8vanbnl2pvyl9kzwzhdwx0x2jhbm5lci5qcgcixv0

Regulatory Affairs Manager - Munich (m/f)

Regulatory Affairs Manager - Munich (m/f)

Job Title: Regulatory Affairs Manager - Munich (m/f)
Contract Type: Permanent
Location: München (81249), Bayern
Industry:
Salary: Negotiable
Reference: DJP 14535_1523613758
Contact Name: Daniel Perkins
Contact Email: d.perkins@sciproglobal.de
Job Published: April 13, 2018 11:02

Job Description

Regulatory Affairs Manager (m/f)

Medical Devices

Munich

I am currently working on an exclusive basis with a fantastic company located in the Munich area. My client is a Global leader within the corner of the Medical Device market in which they are active, and offer the chance to broaden your scope of the market by working with active and non-active products. They are searching for candidates of any experience level, and offer the chance to grow your international experience within their highly dynamic team.

The role:

  • Preparation and Maintenance of technical documentation in accordance with the current European requirements, as well as issuing declarations of conformity
  • Coordination and management of Risk Analysis and biocompatibility studies for the company's medical devices
  • Preparation and revision of instructions for use and labelling materials
  • Handling requests from authorities and notified bodies
  • Assist in Risk Management in the collection, assessment and reporting of incidents to the authorities
  • You will work closely with the R&D departments as well as the Quality Management department, as well as with marketing/sales and medical affairs

Your Profile:

  • Successfully completed studies in a relevant Life Science field or any other comparable areas
  • 2+ Years experience working in Regulatory Affairs for Medical Devices or IVD's
  • Very familiar with the appropriate technical norms and standards
  • Gained first-hand experience in the international approval of Medical Devices
  • Carefully, and precise way of working with a close attention to detail
  • Fluency in both English and German is essential

As stated previously, I am working on this position exclusively, and therefore if you are interested in hearing more about this truly excellent opportunity please get in touch as soon as possible to have the best chance of a successfully application.

d.perkins@sciproglobal.de