A Regulatory Affairs specialist with experience of working with Class 1 and Class 2 Medical Devices is required to join this large organisation and assist them with ensuring all products are compliant with all regulatory requirements prior to launch. This will involve working closely with engineering teams to gather information and provide documentation to the correct authorities.
You will work as a Regulatory Affairs Contractor on problems of diverse scope where analysis of regulatory data requires evaluation of identifiable factors. The development of the solution requires a multi-disciplinary approach and knowledge of regulatory principles, theories and concepts.
- Plan, generate, and coordinate regulatory submissions for existing medical devices in relevant territories
- Coordinate local product registrations
- Maintain existing regulatory filings/ licenses, managing updates and related change control processes
- Responsible for implementing global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy
- Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations
- Review and approve product/solution labeling and product/solution-related marketing communications
- Coordinate testing required to support regulatory submissions
Much more information about this role is available by contacting Carbon60 on 01329 227037
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carbon60 is a trading name of Carbon60 Limited an Employment Business/Agency.
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