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The company is active in everyday healthcare products in the field of cosmetics, medical devices and medicines. Their products are available in over 50 countries worldwide.
Job Description
Acting as Quality operations specialist for Medical device and cosmetics in relations to production and release of medical devices. Acting as CMO responsible for a portfolio of consumer healthcare, which includes medical devices (MD), cosmetics (CS) and food supplements.
Acting as Specialist for business quality in the global department as well as a specialist in the BENELUX region managing complaints, transports 3PL management and local processes as well as provide eventual support to the DACH region. Act as local RA specialist for the consumer healthcare portfolio.
Responsibilities
Quality Assurance
Production and release of MD
Change control of MD
Data and documentation compliance of MD and CS
Primary sparring partner for RA colleagues in RA consumer healthcare
Complaints and root cause assessment from market and assigned portfolio
Local compliance BENELUX and potentially DACH
Other affiliate Scientific Affairs tasks may be included
Labeling compliance and mock-up review
Local regulatory specialist answering to local FAQs on the consumer healthcare portfolio and be liaison to global RA.
Requirements
Bsc
1 year qa or ra experience within a life sciences company
Able to work on site in Rotterdam
Fluent in English and Dutch mandatory
Good to know: This role is open for a temp-to-perm construction.
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