Head of Quality and Regulations
Lead/Head of Quality and Regulations
Location: Cambridge, UK
Salary: Competitive compensation package
Reports to: CEO
Job summary: We are partnering with a high-growth digital in-vitro diagnostic start-up looking for a Lead/Head of Quality and Regulations to join their expanding team. You will be manging and developing the Quality Management Systems and ensuring compliance with ISO 13485 standard. You will be a member of the senior team working closely with the CEO to drive company growth. If you enjoy working in a fast-paced dynamic environment and have a passion for digital technologies, then this role would be a perfect fit.
- Management and development of the company’s Quality Management System (QMS) in compliance with ISO 13485
- Management and development of the company’s existing TF’s for CE, FDA and UKCA marking
- Maintain and improve upon existing standard operating procedures (SOPs)
- Ensure records and references within QMS are kept up-to-date and are fully traceable
- Ensure organization meets regulatory obligations throughout the full product lifecycle
- Accountable for internal and external audits
- Maintenance of the company’s Internal Audit program
- Management of the change control process
- Provide guidelines, support, and training to staff in the operation of quality assurance and control methods
- Ensure effective coordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance
- Update Technical Files for submission to healthcare regulatory agencies internationally
- Work with the Commercial team to prepare marketing applications in new territories
- Accountable for regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging, and communications
- Manages Regulatory Agency and submissions, as required
- Monitor the industry landscape with a particular focus on new regulations and relevant litigation
Qualifications & Experience Required
- Minimum 5 years’ experience working in Quality and Regulatory roles within diagnostic or medical device companies.
- Proficiency in quality systems (ISO 13485), associated documentation.
- Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR).
- Experience in bringing IVDs to market.
- Experience of working in start-up environments a plus.