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Regulatory Affairs Specialist International

Regulatory Affairs Specialist International

Job Title: Regulatory Affairs Specialist International
Contract Type: Permanent
Location: Baden-Württemberg, Germany
Industry:
Salary: Negotiable
Reference: DP 12 4001_1500386036
Contact Name: Daniel Perkins
Contact Email: d.perkins@sciproglobal.de
Job Published: July 18, 2017 14:54

Job Description

I am currently searching for the next Regulatory Affairs Manager within the Medical Device industry with a focus on International regulations

The company is an international MedTech company with its headquarters in Germany. They are focused on developing and creating innovative products for the vascular system.

The main tasks are:

  • International approvals of vascular devices
  • Creation of country specific documents based on CE approvals
  • Representative for liaison with international agents and authorities
  • Techincal submissions
  • Work closely with several other team members with a direct involvement in implementations
  • Supervision and correspondance with external consultants

Your requirements:

  • Completed scientific or technical studies
  • Significant experience within Inernational RA
  • Knowledge of regulatory requirements (EU & FDA)
  • Knowledge of ISO 13485
  • Good knowledge of English and German

If you are, or know anyone that would be suitable with enough experience to become the next RA Manager please either respond to this ad or send an email to d.perkins@sciproglobal.de