Director of Quality and Regulatory Affairs - RCYTHQ0028

  • Operations
  • Cambridge, United Kingdom

Director of Quality and Regulatory Affairs - RCYTHQ0028

Job description

Cyted's mission is to revolutionise diagnostic methods to build a world where disease is prevented rather than treated. We focus on providing digital diagnostic infrastructure to drive the earlier detection of disease. Our technologies use artificial intelligence and novel biomarkers to unlock clinical insight and improve patient outcomes.
The Cyted group develops and deploys digital diagnostic services for research and clinical use. Our services are designed to dignify and empower, placing patients at the heart of our services. 


Cyted is seeking a Director of Quality and Regulatory Affairs to join our amazing team. The Director of Quality and Regulatory Affairs will play a key role in managing the Quality Management System and oversee the various associated duties within an ISO 13485 environment. They will be an accomplished Quality and Regulatory professional with experience forged within the Medical Devices sector dealing with the major regulatory bodies such as MHRA and notified bodies. Knowledge or experience of ISO 13485 and an understanding of other ISO accreditations such as ISO 27001 and ISO 15189.

The role holder should be comfortable working in a fast pace, high growth, start-up environment with interest in improving health care with the use of technology to deliver improved clinical outcomes. A good communicator with a pragmatic approach with ability to working with the development teams as well as interacting with the leadership team to drive the regulatory strategy. They must be able to manage multiple projects, calmly and confidently whilst demonstrating an outstanding attention to detail.

The Director of Quality and Regulatory Affairs must have excellent communication skills, both written and oral and must be confident communicating with individuals at all levels. They will be required to engage with both internal and external stakeholders and develop productive working relationships whilst working to tight deadlines.


Responsibilities:

  • Ensuring compliance with the requirements of the Quality System for implementation of ISO 13485 for Cyted and ISO 15189 and for our laboratory.
  • Develop and implement a quality and regulatory strategy for European markets.
  • Coordinate all activities relating to regulatory compliance, submit specified documentation and act as general liaison with regulatory agencies.
  • Planning, initiating, and managing quality improvement projects.
  • Acting as a point of contact with accreditation authorities, including arranging and planning for assessments.
  • Perform internal audits to ensure compliance to external regulatory requirements.
  • Lead in the role of Risk Management; with knowledge of ISO 14971.
  • Responsible for leading, co-ordinating and monitoring processes such as change control, corrective actions, risk management and ensuring that all requirements are met and records are completed.
  • Provide technical and quality support for projects, ensuring relevant data is completed by the development teams.
  • Drafting and compiling design history files in compliance with in vitro diagnostic medical device regulations (IVDR) and standards for regulatory submissions.
  • Ensuring changes to any relevant standards are adopted in a timely manner.
  • Develop and update technical file(s) and other relevant documents.


Working pattern, location and salary:

The role is a full-time position with a standard 37.5 hour working week. The role holder may be required to work flexibly.

The Director of Quality and Regulatory Affairs will be based at the Cyted’s Head Office, WeWork, 50-60 Station Road, Cambridge, CB1 2JH and will need to visit other company sites if and when required.

Competitive salary.


Benefits:

  • 25 days holiday per holiday year, excluding public holidays
  • Pension scheme
  • A knowledgeable, high-achieving, experienced and fun team
  • The chance to be part of a growing start-up, the next leader in building integrated diagnostics by combining molecular biomarkers with digital solutions
  • Perks at work scheme
  • Free refreshments

Job requirements

Qualifications and background:

  • Undergraduate degree in a science, medical or technical field.
  • Lead auditor qualification.
  • Masters Degree in a science, medical or technical field (desirable).

Experience:

  • Over 5 years’ experience of working in an ISO 13485 environment and IVDR submissions for software based in vitro diagnostic medical devices.
  • Implementation and/or maintenance of ISO 13485 certification.
  • Managing an e-Quality Management System (e-QMS).
  • Experience with writing concise and accurate reports.
  • Working under pressure in a fast-paced environment.
  • Working with multiple parties to edit and refine complex word documents.
  • Participating in internal and external audits.
  • Understanding of software-based medical devices field. 

Knowledge, skills and abilities:

  • Working knowledge of other applicable standards including IEC 62304, ISO 14971, and ISO 15189
  • Outstanding attention to detail.
  • Excellent communication skills, written and oral, at all levels.
  • Tactful, diplomatic, calm, approachable and friendly.
  • Self-motivated and able to work autonomously and problem solve in an ever-changing work environment.

Please contact hr@cyted.ai if you have any questions in relation to this role.