Regulatory Affairs Specialist
Johnson & Johnson Medical BV - Amersfoort (Nederland)
For our client, Johnson & Johnson Medical BV, we are looking for a Regulatory Affairs Specialist.
Ensure compliance with local regulatory requirements, the national and international guidelines and the J&J policies under the Direction of local Regulatory Affairs Lead with regards to Johnson & Johnson Medical and the related project.
Collaborate with Manufacturers, Authorized Representatives and Global Teams, regarding Dutch and Belgian legislation and related requirements.
Essential 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 Belgium, Netherlands and Luxembourg;
- Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, report them to the relevant RA Leaders (at global and local level), 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
Junior scientist (Pharmacist, Engineer, Biologist, Chemist, etc.) and ability to build partnerships internally and externally. Advanced level in Excel (mandatory & non-negotiable).
Core competencies required for this role:
- Ability to analyze, interpret and synthesize regulation and guidelines;
- Ability to identify regulatory issues, risks and priorities, and manage them;
- Consistent skills to work in parallel environments (business and regulation), to provide feedback and background of regulation update and its impact on RA strategy;
- Rigorous and well organized;
- Capability of self-awareness and adaptability.
- Language requirement: Excellent in English and Dutch (write, read and speak);
- Advanced level in Excel (mandatory & non-negotiable);
- Analytical, self-motivated, energetic and self-disciplined person;
- Problem solver;
- Fast learner;
- Good communication skills;
- Attention to detail;
- Able to work in a high-paced environment;
- Knowledge of EU Medical Device requirements will be beneficial
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.
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
As pioneers in medical devices, we continually focus on elevating the standard of care – working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >3200|
Days of leave: 25+11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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