Description
My client is a huge multi national Class III Medical Device company based in Swindon that is now looking for a Senior Regulatory Affairs Specialist - £50-£55,000.Position is responsible for ensuring that domestic regulatory submissions are appropriately developed for approval and clearance of orthopaedic products and their respective accessories. These Regulatory submissions can include, but are not limited to class III design dossiers, preparation of technical files for class I, IIa, IIb (EU), Premarket Approval Applications (PMAs) and Supplements, Investigational Device Exemptions (IDEs), and Premarket Notifications (510(k)s). Ensures regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance.
Key Accountabilities
- Sit on design review teams and provide interactive feedback and assist in the development of supporting documentation.
- Develop Regulatory strategy for projects.
- Assist in the development and implementation of the post-market surveillance.
- Develop documents to submit to Notified Bodies and FDA
- Design Dossiers
- Technical files
- Change notifications
- Premarket notifications (510(k))
- Premarket Applications (PMA) - original or supplements
- Investigational Device Exemption (IDE)
- Develop internal documentation when formal FDA submissions are not required (LTF or memo-to-file).
- Review and approve marketing literature and other items for internal and external dissemination.
- Review and approve all Engineering Change Requests (ECRs).
- Assist in the development and updating of internal operating procedures.
- Submit International registration submission
Required Education and Experience
- Ability to work with a variety of levels both within and outside the organization.
- Knowledge and skills identified are typically acquired by completing Bachelor's or higher degree clinical/science field, or similar work experience.
- Knowledge of domestic/international medical device regulations. Strong computer skills, including word processing, spreadsheet and data programs.
- Strong attention to detail.
- Two to four years' experience in device or pharmaceutical regulatory affairs is desired.
- Working knowledge of FDA and MDD regulations and how to interpret and monitor them.
If you feel you have the correct experience then please send me your CV and I will be in touch shortly.