Regulatory Director - Software as a Medical Device
Zest Scientific recruitment has been instructed to identify a Regulatory Director with global experience registering software as a Medical Device (SaMD). The Regulatory Director will oversee both European and USA submissions, creating a quality system which can support rapid growth.
This is a leadership role where you will develop regulatory strategies for new medical device products which use Machine Learning and AI technology to change patient pathways, improving clinical outcomes for thousands of patients with common Mental Health conditions. The value proposition is particularly strong and the business is experiencing exponential revenue growth.
- Accomplished Regulatory / Quality professional with extensive experience forged within the Medical Devices sector dealing with the major regulatory bodies (MHRA, FDA).
- Exposure to registering software as a medical device.
- 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 Machine Learning to deliver improved clinical outcomes.
- Demonstrates an interest in Mental Health provision and passionate about the opportunity to change the current treatment pathways.
- 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.
- Leadership position with overall responsibility for building a team.
- 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.
- 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 Scientific 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