As an RA Officer you will be part of a Project and ensure compliance with local regulatory requirements, the national and international guidelines and the company’s &J policies under the Direction of local Regulatory Affairs Lead with regards to the Medical Division and related projects. Hereto you will collaborate with Manufacturers, Authorized Representatives and Global Teams, regarding Dutch and Belgian legislation and related requirements.
Essential duties and responsibilities include:
- 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.
Our client is a worldwide operating pharmaceutical company developing and manufacturing vaccines, biologicals, pharmaceutical products and medical devices. In Netherland the company is represented by multiple sites; one of which is responsible for the product portfolio of over the counter drugs and medical devices.
Functie-eisen• You have an MSc or academic BSc in a relevant field (Pharmacy/Engineering/Biology/Chemistry etc) and some (can be internship or project) experience in highly regulated environment (preferred Pharma or Med Devices).
- Knowledge of EU Medical Device requirements beneficial but not a must
- Native Dutch is required; business professional English a must
- You must have demonstrable advanced Excel experience
- 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
- Problem solver
- Strong communication skills
- Must have high level of attention to detail
- Able to work in a high-paced environment
A contract for the duration of the Project and an exciting opportunity in a leading company in the pharmaceutical industry. You will be part of a dynamic and accomplished team. We offer an employment of 36 to 40 hours a week with excellent primary and secondary benefits.. Moreover, Modis offers interesting benefits, like participation of our company-fitness-plan. Modis stands for innovation and stimulates new ways of working. Next to a lot of freedom, you will get the necessary amount of responsibilities, combined with the possibility to develop your ambitions and expertise. Together, we can grow.
How to apply
Please tell us who you are and what motivates you! Send us your application using the application button on this website. Closing date is 5 May 2020.
If you wish to receive more information first, please contact us on email@example.com or contact one of our Recruitment Consultants:
Lars Wijnands on 06-1333 9633
Barbara Flaton on 06-2266 4285
Lars Wijnands on 06-1333 9633
I want to apply now
Please tell us who you are and what motivates you! Send us your using the application button on this website. Closing date is 21 April 2020.