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Regulatory Affairs - Quality Manager (w-m) Munich

Location M√ľnchen (80335), Bayern
Sector
Job Type Permanent
Salary Negotiable
Start Date ASAP
Contact Daniel Perkins
Job Ref MCDP 160890_1525439454

Job Description

Regulatory Affairs - Quality Manager (m-f)

Medical Devices

Munich

 

My client located in Munich is a leader within an industry that is revolutionizing manufacturing. Located in Munich you will experience a start-up environment that is within a leading global technology group. If you are interested in joining a dynamic, forward thinking and driven team, then look no further.

 

The Role-

  • Identification of worldwide Regulatory requirement and relevant standards for the company's medical devices and processes
  • Responsible of registrations, certifications and communications with regulatory authorities along with submitting master files to FDA
  • Define and coordinate alignment in QMS between certified facilities worldwide
  • Collaboration with local Quality Managers as well as R&D and manufacturing activities such as V&V plans
  • Collaboration with application engineers and customers to define regulatory requirements, strategies and plans, as well as technical documentation
  • Training of application engineers and local quality managers on changes in requirements
  • Planning for audit programs for Iso 13485 facilities and sub-contractors
  • Participate in manufacturing audits

 

Your Profile-

  • Obtained a degree in engineering or another relevant field
  • Over 5 years first hand work experience in RA & QM for Medical Devices
  • At least 3 years leading experience
  • Experience with FDA, Health Canada, MDD-MDR
  • Regulatory experience with all classes of devices
  • Strong communication skills, self-motivated, with a positive mind set
  • Fluent in English both written and spoken, and other languages would be a bonus

 

If you are, or know anyone within your network that matches the requirements underlined in this description and you think you have what it takes to join this fantastic organization then please either send your application in response to this advert or alternatively send your CV and cover letter directly to d.perkins@sciproglobal.de

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