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| Job Location | Cambridge |
| Education | Not Mentioned |
| Salary | 60,000 - 80,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Adecco Life Sciences are proud to be working with a diagnostics company that are looking for a Regulatory Affairs Manager to join the team on a permanent basis. As they progress to commercialisation of their product, the Regulatory Manager will lead the development process through relevant regulatory pathways. Responsibilities:* Development and writing of CE marking technical files for IVDs* Knowledge of Clinical process* Set up of Technical Documentation and Design Dossiers in support of the CE marking process and other International Regulatory compliance processes* Conduct/advise on Design/Product Risk Management Activities* Conduct/advise on post market surveillance and vigilance activities* Conduct/advise on validation studies or other technical expert studies for regulatory submissions* Provide medical device expertise in areas of competence to colleagues in the wider Group* Support to obtain, maintain or expand market access to various markets such as European Union and USA.* Provide support and training for in-house staff for medical devices, IVDs and other areas of expertiseRequirements:To be considered for this position, experience with IVDs is essential alongside experience writing clinical or biological evaluation reports.The client is still relatively small in size and so although this is a leadership position, you will be the sole person responsible for regulatory. Therefore, being proactive and hands on throughout each of the regulatory processes is essential.If this role is of interest, please apply and I will be in touch.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 AffairsIVDRegulatory Affairs ManagerRegulatory ManagerIVDR