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Job Location | Sheffield |
Education | Not Mentioned |
Salary | 35,000 - 40,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
Adecco Lifesciences are working with a long-standing and highly successful Medical Device manufacturer who is looking for a Regulatory Specialist to join the team on a permanent basis.As a Regulatory Specialist, you will work within a strong existing regulatory team supporting the company with Technical File remediation to ensure compliance to MDR (2017/745) and assist in the creation of technical documentation for new products being introducedin the New Year.Day to day you can expect to:Create and maintain Technical Files in accordance with EC Regulation 93/42/EEC.Transition Technical Files from Medical Devices Directive (93/42/EEC) to Medical Devices Regulation (2017/745)Compile Technical Files and documentation for review by the Notified Body.Provide regulatory support for all post-market surveillance activities.Maintain and approve product labelling to meet regulatory & UDI requirements. Review marketing, promotional material, and website content for regulatory compliance.Manage and maintain global distributors including UK, Europe, Australia, Canada, and USA. Sound like it might be of interestIf you are adaptable, productive and can work well in a team, you will thrive in this position. As you will be working with high-risk devices, experience with Class iii or Orthopeadic devices is essential to understand the complexity of the technical file you are working with. The business strives to offer each candidate continuous professional development and education allowing you to gain further knowledge in the regulatory field and this role is no different allowing you to build on your problem solving, regulatory strategy, lifecycle management and technical file skills.If this role is of interest and you have the relevant experience, then please apply and I will be in touch to talk in more detail. Spring acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.By applying for this role your details will be submitted to Spring. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.
Keyskills :
ManagementRegulatoryRegulatory AffairsMDRMedical DeviceorthopeadicorthopedicRegulatory SpecialistClass iiiTehcnical files