The company is located in Antwerp and is active in Medical Devices. They have a portfolio of health issue products in the Skin Care. They have a diverse product portfolio.
We are looking for a full time Regulatory Affairs Specialist for the whole product portfolio who has the knowledge in regulations and other standards for the European Market. You will take care over the whole documentation processes of all products. You will work close collaboration with the Sales and Marketing department.
- Preparing product technical files
- Support the Regulatory Affairs department for all product lines
- You will implementation new Regulations for Medical Devices
- Ensure the Regulatory compliance of communication activities and materials like brochure's. presentations and packaging materials)
Your qualifications & experience
- Master Degree in Pharmaceuticals or Life Science related
- 3+ years experience in similar role
- Knowledge of the FDA and European Regulations
- Project Management knowledge is a pre
- English is Mandatory, strong communication skills both written and verbal
- Quality Mindset, strong interpersonal, problem solving and analytical