We're currently looking for a Regulatory Specialist to join them at their flagship site in Leeds on an initial 12 month contract, highly likely to be extended! My client is a global leader in the manufacture of; Healthcare products, Pharmaceuticals and Medical devices/Orthopaedic devices, including the manufacture of instruments used by surgeons for the surgical fitting of the devices.
The Regulatory Specialist will be the expert on technical Regulatory Affairs matters under little or no supervision. You'll be providing assistance in the preparation and submission of global regulatory documents.
Duties & Responsibilities (leadership, people development, planning and execution)
*Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities
*Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
*Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
*Defines data and information needed for regulatory approvals.
*Develops labelling specifications and approves proposed labelling, packaging, advertising and promotional materials after evaluating conformance to regulations.
*Provide Regulatory Affairs support during internal and external audits.
*Plans schedules for regulatory deliverables on a project and monitors project through completion.
*Assists in the development of best practices for Regulatory Affairs processes.
*Represents Regulatory Affairs on cross-functional project teams.
*Partners with other functions to define and obtain data to assist with regulatory submissions.
Job Specific Skills & Experience required:
*Bachelor's degree with minimum 6 years of experience or equivalent
*Practical experience with the preparation and submissions for Class II and III medical devices ( EU and USA)
*Substantial experience of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.
*Knowledge of Additive manufacturing technology and associated regulations (Software), advantageous.
This is an exciting opportunity with a globally recognised organisation, who are the leaders in most health and medical related industries, offering the chance for an experienced Regulatory Specialist to join them on an initial 12 month contract basis, likely for the contract to be extended further than 12 months! They're offering up to £26.28 per hour and it will be based at one of their leading sites in Leeds.
How to apply:
To progress your application or find out more about the role, please contact Dominic at Gold Group or apply for the role online and I'll be in touch with you shortly to discuss the next steps.
This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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