Expert regulatory medical devices & drug device combination product
Posted: 19 May 2022
Administration / Secretarial
For our client, an international pharmaceutical company based in Aubonne, we are looking for an :Expert regulatory medical devices & drug device combination productTasks and responsibilities :
- Provide regulatory expertise for development of Drug/Device combination product.
- Act as the regulatory device lead in developing the Global regulatory strategy for development of new devices that are used in combination or co-packaged with a medicinal product.
- Work closely with the Device development team and devices QA team to define regulatory requirements and submission timelines.
- Review of the device Design history files.
- Assist in the creation and submission of regulatory documents for Health Authorities.
- Assist in the Lifecycle management of drug/device combination products ?globally.
- Experience with regulatory requirements for US/EU/ROW countries for medical devices and co-packaged drug/device combination products
- Understanding of EU-MDR requirements
- Understanding of International regulatory requirements for Medical Devices and Drug/Device combination products
- Experience working on Pharma development teams is a plus
- Experience with notified bodies is a plus
- Ability to handle software needed to support regulatory function for regulatory submission
- od MS office kledge (Excel, Office Timeline)
- Excellent organizational skills, Excellent communication and presentation skills
- od teamwork skills
- od interpersonal skills
- Fluent in English
- Temporary assignment : 6 -9 months, starting ASAP