The Role:Perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, focusing on Module 3.Committed...
To provide regulatory expertise in the research, development and marketing of Advanced Wound Management products and to ensure that regulatory approvals are obtained and maintained in accordance with the agreed registration programme and the needs of the business plans.
To compile, review and approve, regulatory documents in accordance with national requirements to ensure appropriateness and consistency in content and presentation of information both within and between registration applications.
To complete the requirements of the Registration Programme as agreed with senior leadership.
Provide on-going regulatory advice to project teams throughout product and process
development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
Provide advice and guidance, in an expert capacity.
Liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
Review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
Review and approve change control impact assessments for products.
Approval of European Technical Files and regulatory despatches, where appropriate.
To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
An honours degree, in a science subject or equivalent.
Extensive hands on experience within Regulatory Affairs in a Medical Device arena.
Strong understand of regulatory compliance.
Good interpersonal/Team working skills are essential
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.