Regulatory Associate, Medical Devices
The role of Regulatory Associate, Medical Devices is a critical role in successfully delivering innovative medical device projects. Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed regulatory strategies. This role is a great career opportunity for a Regulatory Associate who is highly motivated to succeed and enjoys the fast-moving pace that a small biotech company brings. We are looking for an experienced regulatory affairs specialist to assist with the development and delivery of regulatory documentation for medical devices.
- Working alongside the quality and technical leads writing regulatory and quality documentation for submission
- Prepare documentation for CE marking dossier
- Prepare for and attend meetings with Notified Bodies
- Co-ordinate external contractors and internal Medical Writers/technical experts assigned to the project
- Co-ordinate all device related technical questions i.e. biocompatibility, risk management, toxicology, usability, sterilization etc.
- Bachelor’s degree in a scientific or technical subject
- 5 years + experience in EU regulatory standards with a proven track record of writing and submitting device regulatory documentation to appropriate ISO and FDA standards
- Knowledge of pre-market and post-marketing regulatory requirements and processes for medical devices in EU, as well as knowledge of upcoming changes under MDR
- Excellent written and verbal communication skills
- Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners
For more information or to apply for this position, please contact Amy Lloyd on 01438 842979 or via email on email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46767 in all correspondence.