Description
Due to growth and re-alignment Multi National Medical Device company in the South West of England are now looking for Senior Regulatory Registrations Executive, £30-40,000This role will be principally responsible for compliance with all prevailing medical devices standards and leading the creation and maintenance of all technical files, design dossiers and device master records including certification and all other important documentation for devices.
Key responsibilities include;
- preparing documents for registrations of devices in countries identified by the business
- keeping abreast of international legislation and guidelines to facilitate market entry and communicating this to the business
- communicating with the local authorities/local distributors to ensure on time registration of products
- Prepares regulatory documents for product approval
- monitoring and setting timelines for license renewal/approvals including maintaining companies' device listing and establishment registration with FDA
- advising internal stakeholders of on regulatory requirements including time and cost of registration
- providing country specific regulatory requirements for product registration throughout the development of a product
- specifying storage, labelling and packaging requirements in line with registration requirements
- maintains a performance and improvement culture and shares best practice where possible
- provides appropriate input into budget and forecast development line management of the Registrations team
Essential Requirements;
- A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs; the length of which is dependent on the level of qualifications achieved
- Sound Medical Device experience, including a successful track record in the registration and maintenance of products within the Europe, Asia and Middle East region
- Experience working with international regulatory bodies within the medical device industry.
- Sound knowledge of relevant Quality Standards.
My client is looking to pay from £30,000 to £40,000 for the right candidate and is currently interviewing so if you believe you have the right experience then please send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com