Regulatory Affairs Manager
Location: United KingdomSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Cambridgeshire United Kingdom.
- Identify and communicate the relevant regulatory requirements
- Ensure compliance of device technical files
- Compile and adapt the necessary product technical documentation to fulfil requirements from different jurisdictions
- Address regulatory requests from customers
- Cooperate with distributors and subsidiaries on product registration
- Liaise with the relevant regulatory bodies and competent authorities
- Raise awareness and train staff in regulatory issues relative to medical devices
- Monitor regulatory activities (regulations, standards, guidelines) relevant to the company products
- Implement post-marketing surveillance activities, including vigilance of medical devices.
- Confirmed experience in a similar position in Medical devices sector
- Excellent written and spoken level in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
The Company
Our client is a global Medical Device company in CambridgeshireRole Description
Regulatory Affairs ManagerResponsibilities
- Ensure the application of regulatory requirements in all processes, liaising with the Quality System Manager- Identify and communicate the relevant regulatory requirements
- Ensure compliance of device technical files
- Compile and adapt the necessary product technical documentation to fulfil requirements from different jurisdictions
- Address regulatory requests from customers
- Cooperate with distributors and subsidiaries on product registration
- Liaise with the relevant regulatory bodies and competent authorities
- Raise awareness and train staff in regulatory issues relative to medical devices
- Monitor regulatory activities (regulations, standards, guidelines) relevant to the company products
- Implement post-marketing surveillance activities, including vigilance of medical devices.
Requirements
- University degree in Engineer, technical or medical- Confirmed experience in a similar position in Medical devices sector
- Excellent written and spoken level in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
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