Regulatory Consultant for CDx development projects

Are you an experienced Regulatory Affairs Consultant with a passion for working with companion diagnostics? Are you skilled in obtaining regulatory approvals from FDA and EMA and have a proven track record of successfully writing PMA/510(k) submissions?

If so, we are seeking an experienced individual for an 6-18 month project as a Regulatory Affairs Consultant, specialising in Companion Diagnostics.

This is a full time contract offering a competitive rate and the opportunity to work across all stages of the regulatory process, from concept to PMA.

We are looking for an individual with a minimum of five years' experience working with IVD and/or medical devices, who is well-versed in the regulations surrounding IVDR. You will need to be able to provide input on regulatory strategy and also be confident in communicating with regulatory bodies and attending meetings when necessary.

The successful candidate will be a proactive self-starter with a keen eye for detail, able to work autonomously and proactively manage your own workload. You will also need to be confident when it comes to interacting with pharmaceutical partners and building successful relationships with them.

This role offers a chance to join a market-leading organisation, working with  in the fast-paced field of Companion Diagnostics. You will have the opportunity to work alongside experienced professionals and to grow and develop your skillset.

If you feel you have the necessary skills and experience, then we'd love to hear from you. Please send your CV and covering letter to hannah.hughes@catalystcareers.com and we will be in touch shortly.