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Regulatory Associate, Medical Devices
Company: 30 Technology
Location: Oxford, UK
The role of Regulatory Associate, Medical Devices at 30 Technology 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.
This role is based in Oxford, UK.
Working alongside the quality and technical leads write 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
30 Technology was created as a group of seven wholly owned subsidiaries aligned to its research programs and market verticals:
30Respiratory, 30Woundcare, 30Therapeutics, 30Pharma, 30Dermatology, 30AnimalHealth and 30Innovation.
30 Technology aim to unlock and deliver the promise of therapeutic nitric oxide by developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.
Nitric oxide (NO) is a volatile gas, produced in tissues of the body, which acts as a vital cell-to-cell signalling mechanism. The discovery NO is involved in a number of critical physiological processes led to a 1998 Nobel Prize. Since then, a number of attempts have been made to harness its multiple therapeutic effects which include increased blood flow, regulation of immune response, abroad-spectrum anti-microbial activity and acceleration of healing.
However, NO has a very short half-life, so sustained release and practical delivery is difficult to attain. 30 Technology has solved these previously intractable problems, utilizing proprietary IP to create a platform technology which uniquely creates the opportunity to use NO in a variety of diseases and health conditions.
Additionally, our revolutionary 30Technology™ Intellectual Property allows us to deliver sustained NO into the lung via aerosol, through the skin via topical patches, gels, liquids and into the body for release from biomaterials in regenerative medicine.
Our technology is clinically proven and a potent solution to many serious medical conditions.
To achieve its goals, the 30 Technology has been highly successful in its first round of funding, raising more than £30m. The lead investor is Morningside Ventures, the Harvard, Boston-based Lifescience VC with an international reputation.
30 Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
To apply for this vacancy please get in touch with the recruiter using the details shown above.