Description
This is a newly created, highly visible position with responsibility of moving all new and existing woundcare products in to new territories whilst dealing with all RA/QA workload for existing product pipeline.Main Responsibilities;
- Work alongside the Group Medical Director to drive the successful launch of a new wound care product by providing best-in-class labelling, rapid approval of line extensions and co-ordinating technical support
- To provide expert regulatory knowledge and support for registration in the EU and the internationalisation of the wound care portfolio
- Assist the Manager Regulatory Affairs Established Products obtain new marketing authorisations and maintain existing authorisations
- Develop, maintain and update all regulatory dossiers for medical devices for European and other key International Markets.
- Prepare and execute the regulatory strategy for agreed new medical device products for European and other Key International Markets securing buy in and support from commercial and development colleagues.
- Provide expert management of the regulatory responsibilities to support medical device products portfolio.
- Provide responses and updates of any Design Dossier File following Notified Body and Regulatory Authority questions during any assessment phase and post approval when required
- To provide and maintain an overall understanding of the project and key deadlines
- Design process - manage and control to ensure the process is being followed and records are maintained to meet processes
- Identify, document and implement all regulatory including pricing and reimbursements requirements for woundcare market entry in all target territories
Essential Requirements;
- A knowledge and understanding of medical devices and the regulatory requirements for marketing such products in Europe, the Gulf States, Asia and Australia.
- Proven track record of achieving the required regulatory certification to bring medical devices to the market
- A broad understanding of new product development for medical devices, coupled to experience and driving development teams working on novel formulations and presentation formats
- Previous Experience in the registration and maintenance of marketing authorisations for medical drug products
- Ability to work cross-functionally within organisation.
- A desire to support the marketing and sales functions in achieving their commercial targets
- At least 3 years experience in the registration of drug products.
If you are looking for an opportunity in an exciting and succesful business then please sen me your CV and I will be in touch shortly
To find out more about Real please visit www.realstaffing.com