Senior Manager Device Quality

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. Germany
Berlin, Germany
Posting date: 15 Apr 2021
36937

A vacancy has arisen for a Senior Manager of Device Quality at a large biotech. This role is responsible for overall Medical Device Quality & Compliance leadership,from Combination Product development to commercial manufacturing. This role is based within Europe and is an exciting opportunity to over Device Quality programmes.

Job Responsibilities

  • Establish Quality Management Framework for Medical Device/Combination products to support compliant product lifecycle processes.
  • Work according to the requirements of EU, FDA and another national Medical Device legislation (as applicable).
  • Build and further develop capabilities in the organizationto enable flawless execution & good business outcomes
  • Drive simplification & standardization of the QMS in line with overall quality strategies & initiatives
  • Establish international and regional /local relationships with RA, other QA Groups, Manufacturing, Development and Management
  • Ensure continuous regulatory knowledge as necessary for the business.
  • Review and approve deviations and change controls from Suppliers and Contract Manufacturers
  • Participate in Medical Device related audits and regular inspections
  • Establish training curricula for QA oversight of Medical Device activities
  • Write, review and approve applicable Quality System documents as needed

Skills & Qualifications

  • Excellent written and oral English communication skills
  • Bachelor's Degree education in Pharmaceuticals, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality/Regulatory leadership roles.
  • +5 years experienced working with EU, FDA, ISO 13485, ISO 14971 and other global Medical Device regulations
  • Strong collaboration skills and ability to build partnerships internally and externally
  • Change management experience and influencing skills

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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