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RA Specialist Medical Devices
A challenging Regulatory Affairs positions with a European scope in the in-vitrodiagnostic field
Het bedrijf / The company
Our relation is an international Healthcare organization. They are active in the development, production and sale of medical devices, (medical) food and medicines worldwide. They are experiencing significant growth. In order to further develop the success of their products and the regulatory affairs for the medical devices, we would like to get in touch with an RA Specialist Medical Devices.
De functie / The role
As a Regulatory Affairs Specialist Medical Devices, you support the RA Manager Europe and importer activities. You are actively engaged in the execution of plans to ensure compliance with regulations that impact the company’s business. Also, you will manage the document management system.
Furthermore, you will help develop strategies to ensure regulation compliance and you make sure that necessary documentation is completed and submitted. You will perform the necessary product-related verifications before medical devices are made available on the European market. Of course, you support in timely vigilance notifications to the Dutch competent authority. And you manage the device registrations in both national and European databases.
Het profiel / Your profile
• BSc. or MSc. degree, preferable with a scientific orientation (i.e. Laboratory Technology, Medical Biology, Medical Technology, Chemistry, Pharmacy)
• at least 2 years quality or regulatory experience in the field of medical devices or in-vitro diagnostic devices
• experience with device registrations preferred
• experience with medical device vigilance notifications preferred
• fluent in both verbal & written English
• at least basic knowledge of Dutch
• multitasks, prioritizes, and meets deadlines
Het aanbod / The offer
• a challenging job within a global healthcare company
• an operational role in a international environment
• a temporary contract for 1 year, with the possibility to extend
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-119-FMF, to Jamie van der Heijde : firstname.lastname@example.org.
For further information, please call Jamie van der Heijde at number +31 (0)33 472 80 87.
Tenslotte ..... / Finally ....
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.