A London based Start-up Medical Device company developing a Class 1 Measuring Device is on the look out for a Regulatory Affairs Manager to support their growing business.
They are looking for an individual that is hard working and self motivated to assist with all things regulatory. Responsibilities will include:
- Oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
- Working with Notified Bodies, taking the product through to FDA and FDR approval.
- Provide regulatory guidance and support, ensuring compliance with EU regulations, and assist in third-party audits.
- Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements.
- Manage project assignments for investigational, new, and marketed products.
- Liaise with government agencies and gather regulatory intelligence.
Competencies:
- More than 7 years' experience in regulatory affairs, ideally gained within a Medical device business.
- Expert knowledge of MDR, ISO13485, UK MDR.
- Experience interacting with Notified/Approved Body.
- Ideally experince within orthopedics or surgical devices.
Please share your CV at if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.