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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP

Location: Germany

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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