Quality & Regulatory Manager - Disruptive Tech
Zest Medical is working with one of Europe’s hottest Digital Health start-ups to identify a Quality & Regulatory Manager to lead the Quality Assurance and Regulatory Affairs function. The disruptive tech provider has the potential to revolutionise the way individuals are treated for common Mental Health conditions, applying pioneering technology to create novel treatments.
The Quality & Regulatory Manager will be required to work from both the London and Oxford offices developing regulatory strategies for pioneering treatments.
- Accomplished Regulatory / Quality professional with experience forged within the Medical Devices sector dealing with the major regulatory bodies (MHRA, FDA).
- Knowledge or experience in one of the following: ISO 13485; 21 CFR 820; 510K.
- Comfortable working in a high growth / start up environment.
- Interest in Digital Health and the potential of technology (Virtual Reality) to deliver improved clinical outcomes.
- A good communicator with a pragmatic approach – working with Tech Development teams as well as interacting with the leadership team to drive the regulatory starategy.
- Develop and implement a quality and regulatory strategy for UK and US markets.
- Coordinate all activities relating to regulatory compliance, submit specified documentation and act as general liaison with regulatory agencies.
- Provide input to development teams on device design and process verification.
- Work with a high degree of autonomy, this is a transparent role.
- Provides an excellent platform for personal development working in an organization which is going through rapid scale up with the opportunity to build a team and recruit additional sales personnel as the company continues to grow.
- Evidence based Digital Health company which is changing patient pathways and delivering improved clinical outcomes for patients suffering with some of the most common Mental Health conditions.
- Clinically validated and user focused technology which has the scope to enable wide access to the best therapies.
- High growth business experiencing exponential growth.
- Innovative pipeline of new services and opportunities for further market penetration.
Our client is committed to securing the services of the right candidate and is flexible with regards to the remuneration package available. Zest Medical is working to a strict deadline so in order to be considered for this opportunity please apply now and your application will be reviewed immediately.
Contact: Matthew Morland
Telephone: 0114 238 1724