ANGLE is a world leading and growing liquid biopsy company that develops products for use in rare cell diagnostics that enable early, accurate identification of an individual’s condition for the prevention, treatment, and monitoring of disease. ANGLE’s research and development facilities in Guildford, UK are looking for a Regulatory Manager to work in close collaboration with our Research and Development team in developing our circulating cell isolation and multiplex molecular analysis products.
- Provide leadership and comprehensive input to research and development projects regarding analytical and clinical evidential requirements and data gathering activities (studies) for regulatory purposes.
- Preparation and maintenance of materials required to support regulatory approvals and clearances.
- Provide leadership to the research and development team in the deployment of NPD procedures where specifically related to analytical and clinical verification and validation and other regulatory matters, and in line with the Company ISO13485 quality system.
- Keep up to date with current analytical and clinical regulatory standards and requirements as relevant to ANGLE’s desired areas and locations of business; and apply such knowledge to day to day activities.
Qualifications, Experience, Knowledge and Attributes:
- Previous experience of working in a similar role within the medical devices sector and experience of developing regulatory pathways with a proven track record of approvals worldwide.
- Excellent knowledge of global medical device directives and regulations, MEDDEV guidelines, ISO standards, US FDA and worldwide regulatory requirements.
As a member of our excellent and fast-growing team you will receive opportunities for development and a competitive benefits package. Salary estimate – £competitive.
Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.