About the Role:
I am partnering with one of the world's leading specialist Medical Device companies to find a Senior Regulatory Affairs Associate to be based in their new UK site in Berkshire.
The Senior Regulatory Affairs Associate EMEA will be responsible for interacting with the Notified Body and Competent Authorities on regulatory matters as well as providing regulatory support and expertise by developing EMEA regulatory strategies and submissions.
The successful Senior Regulatory Affairs Associate will need knowledge and experience of Medical Device Regulations in the EMEA region and around 3 years of industry experience, the ability to analyse technical data and be comfortable liaising with regulatory bodies.
Key Responsibilities include:
- Provide regulatory advice and support to the business in relation to the registration and conformity assessments of medical devices in the EMEA region.
- Supporting Global Regulatory Affairs in creation and maintenance of essential requirement checklists, technical files, and declarations of conformity for CE Marking
- Will be a liaison with regulatory agencies and notified bodies regarding regulatory matters Assists in the preparation of agency meeting packages and strategies for agency meetings.
- Plans and organizes registration submissions to regulatory agencies and notified bodies. Prepares and maintains registration packages in line with European Union or EMEA international regulatory requirements and guidelines. Region includes EU, Middle East and Africa.
- Evaluates product, process and labelling changes for regulatory impact.
- Responsible for regulatory approval as part of sales enablement of product for EU distribution.
- Local regulatory contact for the EMEA Medical Device commercial team.
If this opportunity aligns with your career aspirations, please get in contact with Lillie Fenlon-Billson at Real Staffing on l.fenlon-billson @ [... Click Apply...]
Sthree UK is acting as an Employment Agency in relation to this vacancy.