Regulatory Affairs Specialist
An exciting new opportunity has arisen for an experienced regulatory affairs specialist within the medical devices industry. My client is a world-leader in medical diagnostics, specialising in the research, development and manufacture of innovative products focused on Multiple Myeloma, and other immune disorders. My client is expanding rapidly into new territories over the coming years, and is entering a recruitment drive to reflect that market growth. In this role as a regulatory affairs specialist, you will be based in the client’s UK headquarters in state-of-the-art facilities, and your role will include:
- Knowledge of internal procedures, processes and document stores.
- Able to analyze and interpret complex data.
- Can offer general advice on regulatory strategy for new products and product changes
- Can complete a 510k submission with minimal supervision.
- Can undertake CE marking activities and has a good understanding of the requirements of the IVD directive.
- Able to recognize post market surveillance issues that require corrective action and reporting.
- Can liaise directly with international regulatory agencies and provide supporting documentation, handle queries and issues
- To contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality System.
- To update on the progress of registration processes and other RA group activities to line management when requested.
- To be responsible for planning own workload and works with limited input from the line manager, influencing personal training and assisting in setting appropriate time lines for projects.
- To assist with the regulatory compliance of marketing communications/messages for the Binding Site products and services.
The ideal candidate will, ideally:
·Possess a degree in a relevant field
·Have demonstrable experience in a similar role
·Be an excellent communicator (both written and verbally)
·Have experience with IVD’s, ISO 13485 and 510k’s
·The ability to speak a foreign language is not essential, but would be beneficial to the role.
My client is an equal opportunities employer and welcomes applications from anybody who can prove their rights to work in the UK.
This job was originally posted as www.totaljobs.com/job/75270296