We are seeking a proactive individual to provide customers and internal project teams with expert advice on medical device regulations and assist with the clinical translation of research prototypes, in particular active implantable medical devices and multi-modal surgical instruments. This is an exciting opportunity to support the development of state-of-the-art solutions to healthcare challenges and improve research impact.
The Regulatory and Clinical Research Associate/ Specialist will be part of a team established to support a new cleanroom production facility (MAISI) in taking complex medical device prototypes to first-in-patient investigation. The post holder will be expected to support the development and production process; advising on the regulatory requirements for all risk classes of device, including software and hardware. Additionally, they will assist with the generation of Clinical Evaluations and Technical Files, as well as obtaining MHRA approvals for clinical investigations as appropriate.
The post holder will also work closely with the University’s partner Trusts, including colleagues from Guy’s & St. Thomas’ hospital’s department of Medical Physics to develop processes to ensure technical documentation produced by the School is suitable for clinical investigation submission.
This post will be offered on a fixed-term contract for 2 years.
This is a full-time post (35h per week).
- Provide advice and develop guidance for customers and device development teams on regulatory approval pathways and requirements, including clinical investigation requirements for first in human use.
- Liaise with the MHRA, local clinical trials offices, research offices and clinical engineers within NHS Trust partners to facilitate translational process of devices for use in the clinic.
- Be proactive in understanding new regulations and standards and advising on how this will impact processes to help ensure organisation’s compliance with applicable regulations.
- Coordinate and support the review of technical documentation prior to submission for approval for first-in-patient clinical investigation.
- Assist with completing the IRAS Form and preparing submissions for Clinical Investigations.
- Provide support and advice on creation of clinical evaluations and regulatory technical files.
- Support the operation and compliance of the Quality Management System including management of QMS training records.
- Support document control activities.
- Support the Medical Engineering Quality Systems Manager in liaising with competent authorities and notified bodies for cleanroom and quality system certification.
- Provide support during internal and external audits.
- Work in collaboration with other members of the quality and cleanroom teams to develop fit-for-purpose processes.
- Develop, organise and participate in internal training sessions and external seminars.
- Conduct internal audits including regular reviews of device technical files to ensure compliance (grade 6).
- Advise project teams on methods to demonstrate device safety and other essential requirements, including but not limited to testing requirements for biocompatibility, toxicology, usability and sterilisation as applicable (grade 6).
- Participate in design reviews (grade 6)
- Coordinate and review clinical evaluations (grade 6).
- Advise on labelling specifications and IFUs to conform to regulations (grade 6).
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
1. HNC, A level, NVQ 3, HND level or equivalent with relevant vocational experience.
2. Previous regulatory experience in industry, notified body, competent authority or equivalent (preferably with Class IIb/III medical devices).
3. Knowledge of relevant systems, policies and legislation for medical devices, including Regulation (EU) 2017/745 and Council Directive 93/42/EEC.
4. Experience of compiling regulatory and/or quality system documents for regulatory compliance.
5. Excellent organisational, written, verbal communication skills and ability to troubleshoot.
6. Good interpersonal skills to develop and maintain effective working relationships and work as a team.
7. To embrace the challenge of setting-up a new facility in an academic and clinical setting, and be flexible, open-minded and creative with innovative ideas and a can-do attitude to provide solutions to establish a compliant facility.
Additional essential criteria (Grade 6)
8. University or a technical college degree or equivalent qualification in relevant studies, e.g., medicine, pharmacy, engineering or other relevant studies; or broad vocational experience acquired through a combination of job-related vocational training and considerable on-the-job experience, demonstrating development through involvement in a series of progressively more demanding relevant work/roles.
9. Experience of writing, reviewing and approving regulatory and/or quality system documents for regulatory compliance.
10. In depth knowledge of Clinical Investigation regulations and standards e.g., ISO 14155 and their application.
11. Experience of creating and maintaining regulatory documents (e.g., Essential requirement/GSPR checklists, clinical evaluations, and technical files)
12. Experience preparing regulatory submissions for clinical investigations or conformity assessments.
- Knowledge of testing requirements for biocompatibility, toxicology, usability and/or sterilisation of medical devices.
- Knowledge and experience of Quality Management Systems (ISO 13485) and Risk Management (ISO 14971).
- Experience of notified body inspections and other audits.
- Experience of liaising with approved/notified bodies and competent authorities.
- Experience applying for permission to conduct a clinical investigation through the UK’s Integrated Research Application System (IRAS).
During the interview, the candidate will be asked to give a 10 minute presentation.
This post is subject to Disclosure and Barring Service clearance.