Senior Manager RA Devices

CK Clinical
£55000 to £60000
16 Oct 2016
15 Nov 2016
Contract Type
Oliver Care is recruiting for a Senior Manager for Regulatory Affairs Medical Devices to join a global, technology-driven multi-specialty health care company at their site based in Marlow on a permanent basis.

The main purpose of the role will be:
-To provide clear, constructive regulatory advice and guidance to global project and regulatory teams.
-To ensure effective planning, tracking and archiving of activities, especially submissions, internal memos and key correspondence.
-To independently and without supervision, prepare complex regulatory documents for product approval in EAME.

Further responsibilities will include:
-Providing effective technical/scientific input to the Brand Teams, supporting the development and review of compliant promotional materials.
-Reviewing labelling and packaging components to ensure accuracy and compliance with governmental regulations.
-Working with regional commercial teams, agree priorities and clearly convey project timelines, risks and opportunities.
-To maintain Design Dossiers and Technical Files ensuring contents are current and accurate.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level in a Life sciences or related field.
-Must have extensive medical device experience in Regulatory Affairs, including a successful track record in the registration and maintenance of products within Europe.

This is an excellent opportunity to join a multi-speciality, global pharmaceutical company that delivers leading, innovative products.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37348 in all correspondence.