Do you have experience in a highly regulated environment and are you in for a new challenge? This may be something for you!
In this role you’ll ensure compliance with local regulatory requirements, the national and international guidelines and the companies policies. You’ll 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.
- WO level BSc in a relevant field (Pharmacy/Engineering/Biology/Chemistry etc)
- Native Dutch required; business professional English
- Must have demonstrable advanced Excel experience
- Experience in highly regulated environment (preferred Pharma or Med Devices).
- Knowledge of EU Medical Device requirements beneficial
- Strong communication skills
- 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.
A great job opportunity at one of the world's most comprehensive and broadly-based manufacturer of health care products.
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: email@example.com Kenmerk: 9502.