CLS Services

Gepubliceerd: about 1 month ago

Regulatory Affairs Assistant

Amersfoort
Gepubliceerd: about 1 month ago
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Johnson & Johnson Medical BV, we are searching for a Regulatory Affairs Assistant .

Company profile
Johnson & Johnson Medical werkt samen met ziekenhuizen en zorginstellingen aan het optimaliseren van de zorg vanuit haar core business: medische producten, instrumenten en services.
Met kantoren in Dilbeek (B) en Amersfoort voorziet Johnson & Johnson Medical het merendeel van de ziekenhuizen in de Benelux van producten en services van DePuy, Ethicon en Ethicon Endo-Surgery.
Johnson & Johnson Medical is onderdeel van Johnson & Johnson, ’s werelds meest omvangrijke en veelzijdige fabrikant van healthcare producten en leverancier van aanverwante diensten.
Met ruim 100 jaar ervaring concentreert de ‘Johnson & Johnson family of companies’ zich op de medische, consumenten- en farmaceutische markt met een sterke focus op onderzoek gebaseerde en technologie gedreven producten. Tekenend voor het bedrijf zijn het decentraal management, de lange termijn visie en het werken volgens de ethische principes vervat in het Credo.
De werknemers van Johnson & Johnson werken samen met partners in de gezondheidszorg en bereiken met hun portfolio dagelijks miljarden mensen wereldwijd. En, zolang er mensen zijn van wie de gezondheid te wensen over laat blijven zij streven naar innovatie.



Job description
Are you interested in Regulatory affairs and would you like to develop more in this field? Are you fluent in both Dutch and English? This can be a excellent challenge for you!

In this role you ensure compliance with local regulatory requirements, the national and international guidelines and the J&J policies under the Direction of local Regulatory Affairs Lead. You collaborate with Manufacturers, Authorized Representatives and Global Teams, regarding Dutch and Belgian legislation and related requirements.
Duties and responsibilities:

  • Label and Instruction for Use – review and approval, and the management thereof;
  • Update of RA database;
  • Handle all necessary activities for the release of SKU (codes) restrictions;
  • Local Management of the MV Project and related communication to all stakeholders;
  • Ensure regulatory compliance of Medical Devices (MD) for their access to the market of the BeNeLux;
  • Identify Regulatory Issues & strategies concerning MD, in the scope of the project, report them to the relevant RA Leaders, investigate and suggest solutions to resolve them;
  • Support for One MD Organizations in Netherlands and Belgium related to the project;
  • Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs, and act as the main contact person for any natters related to the Project impact issues;
  • Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure flawless completion of the Project and related activities, and accurate and timely reply to stakeholder requests.


Who we're looking for
To successfully fulfill this role, we are looking for a BSc or MSc candidate in a relevant field like Pharmacy, Biology, Chemistry etc. We are looking for a native Dutch speaking candidate who is business professional in English. You have experience with a pharmaceutical or medical devices environment. Knowledge of EU Medical Device requirements is benificial for this role. Additionally you must have demonstrable advanced Excel experience. As a person we are looking for analytical candidates with good problem solving skills. You are a good communicator and have a good eye for details. Are you the RA candidate we are looking for?

Additional vacancy information
Reference: A2000049
Contract: Projectmatig dienstverband met CLS Services
Education: HBO/BSc.
Terms: Project for at least 5 months, longer term possibilities anticipated, depending on business results. Full time highly preferred, 32 hours can be discussed.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555

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Vacature details

Fulltime / parttime

Vakgebieden Betabanen

Carrièreniveau