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Senior Safety Officer for Medical Devices

  • Job type: Permanent
  • Location: Munich
  • Salary: Competitive
  • Job reference: SETH20122017
  • Sector: EPM Scientific, Quality
  • Date posted: 20/12/2017
Job Description

A World Leading global manufacturer of precision bearings and components is seeking an experienced Senior Safety Officer for Medical Devices to be based in Germany. The Safety Officer for Medical Devices will manage the construction of an ISO 13485 certified QM system and shall conduct clinical and risk assessments.

Company Overview

This company is an industry leader and a globally recognised brand in precision bearings and components. My client prides itself on its employee-centric culture, which promotes steady development, global opportunities and un-paralleled training.

Responsibilities:
  • Management of the construction of an ISO 13485 certified QM system
  • Assumption of responsibilities as safety officer for medical devices according to §30 MPG
  • Conduct clinical and risk assessments
  • Definition of specifications for product development based on valid guidelines and applicable standards
  • Cooperation with testing centers and authorities
  • Operation of the approval of a medical device class IIb
  • Initiation of clinical trials as a sponsor
  • Collaboration in an international team in the realization of a Bed Sensor System for automatic acquisition of vital parameters
Skills
  • Completed science, medical or engineering degree
  • At least 2 years of professional experience, preferably in the area of Quality Assurance / Regulatory Affairs
  • Experience in working with test centers preferably in the field of MPG or AMG
  • Good project management skills
  • Experienced in the conduct of searches and evaluations as well as the structuring of procedural instructions
  • Safe English spoken and written
  • Performance motivation, personal responsibility and willingness to change
  • Business Fluent German
 

Package:
  • Ongoing training and career development
  • Flexible working
  • Private healthcare and life assurance
  • 33 days holiday (inclusive of bank holidays)
  • Group pension plan
  • Employee of the quarter, food treats and staff parties.
  • Subsidised restaurant and have free parking at our site
 

Apply:
  • Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: apply.a33ho1gkskv@epmscientific.aptrack.co.uk or phone +442038712405
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