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Location: Newcastle upon Tyne
Regulatory Affairs Officer
This is a great opportunity to join a leading life science company at an exciting time in the business. It could be an excellent move for a life science professional looking to make a first move into regulatory affairs, from either a lab role or a quality assurance position.
The role position will have responsibilities for supporting tasks associated with the site regulatory obligations, you will follow existing policies, procedures and work instructions to plan and conduct tasks. Working closely with the RA manager, the role will involve responsibilities in the following areas:
Adverse events and patient safety
Support the review and analysis of product complaints, clinical reports and other data against established processes and procedures.
Support and organize safety and filing decisions.
Support and organize the review and approval of labeling, advertising and promotion for compliance to applicable regulations
Support Senior RA Officers, RA management in the implementation of new regulations.
Submissions, registrations, device listings, site licenses
Work with global colleagues in support of product registrations and submissions.
Establish and maintain official site regulatory files according to government expectations and company procedures
Serve as site RA representative on new product development teams and change management initiatives
Establish and maintain device listings and licenses according to government requirements
Support the documentation of regulatory strategies
Ideally the successful candidate will have a BSc (or equivalent) in a relevant scientific discipline. Some experience in medical device Regulatory Affairs would be hugely beneficial, but just an understanding of the workings of regulatory guidelines/submissions will be useful. Apply now with your CV, and feel free to contact Tom Kirkpatrick at CY Partners.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.
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