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Regulatory Affairs Manager - IVD's

Regulatory Affairs Manager - IVD's

Job Title: Regulatory Affairs Manager - IVD's
Contract Type: Permanent
Location: München (81249), Bayern
Industry:
Salary: Negotiable
Reference: JDP 90129_1504105305
Contact Name: Daniel Perkins
Contact Email: d.perkins@sciproglobal.de
Job Published: August 30, 2017 16:01

Job Description

I am currently searching for a Regulatory Affairs Manager that has experience within the area of IVD's to take on a really exciting role at a leading global company.

The company invest very highly into the development of individuals and this opportunity will certain lead to a career progression


The position:

  • They provide necessary documents for the registration, declaration of conformity and approval from the specialist departments.
  • In addition, you are responsible for the authorization-relevant examination of product changes, the execution and tracking of the resulting measures as well as the creation of change announcements.
  • They create dossiers or their precursors in accordance with the legal and regulatory requirements of the target countries in English.
  • In addition, you coordinate the requirements and solutions with colleagues from the areas of development, production and quality control, as well as the registration officers.

Your Profile:

  • You have successfully completed your studies in natural sciences
  • They have already gained practical experience in laboratory diagnostics (R & D, clinical trials, quality control), approval or quality management
  • You are already familiar with regulatory requirements (laws, standards, etc.) for IVDs.
  • In addition to good English language skills, you also have good data-processing skills (MS-Office, databases, document management)

If you are, or know anyone that is interested in this fantastic opportunity, please either respond to this advert or send an email with your CV to d.perkins@sciproglobal.de