Job summary
We have an exciting opportunity to recruit a Regulatory Compliance Manager at UCLH to a fixed-term post, to lead on compliance of medical device manufacture and modification, to current Medical Devices Regulations including implementation of an ISO13485 Quality Management System.
We are looking for a talented and highly motivated individual with demonstrable leadership, co-ordination and communication skills with a passion for delivering quality improvements.
If you have experience of working with Quality Management Systems, leading improvement initiatives and knowledge of medical device regulations relating to manufacture and modification within a healthcare environmentwe would love to hear from you. Please ensure you share your specific experience in your supporting information as part of your application.
The successful candidate will ideally be HCPC registered as a Clinical Scientist (or eligible to register with evidence of commitment to complete registration).
Interviews are to be held on 29th February. Applicants must be able to attend an on-site interview.
Main duties of the job
The successful candidate will proactively lead on the implementation of an ISO13485:2016 Quality Management System in the Medical Physics and Biomedical Engineering Department at UCLH. Initially this will be for the manufacture of Cranioplasty Implants but there will be potential to extend the scope to manufacture and modification of other medical devices including software.
The post holder will be expected to lead the project including the management of timelines, co-ordinating involvement from existing Clinical Technologists and Clinical Scientists responsible for design, development and manufacture of medical devices, supervision of junior members of the team and reporting to senior colleagues. The post holder will be expected to develop appropriate documentation as required and ensure it is recorded in the electronic QMS database.
In addition, the post holder will be responsible for improving awareness of medical device regulations within the department and wider Trust and advising and leading on any changes resulting from revision of the Medical Devices Regulations.
Knowledge of Quality Management Systems and Medical Devices Regulations as well as experience of managing projects with a great attention to detail and excellent communication skills will be vital.
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
- University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
- National Hospital for Neurology and Neurosurgery
- Royal National ENT and Eastman Dental Hospitals
- University College Hospital Grafton Way Building
- Royal London Hospital for Integrated Medicine
- University College Hospital Macmillan Cancer Centre
- The Hospital for Tropical Diseases
- University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
Person Specification
Knowledge and Qualifications
Essential
- First and Higher Degrees in a Physical Science or equivalent subject (or equivalent)
- State Registration as a Clinical Scientist (or eligible to register with evidence of commitment to complete registration with HCPC)
- Evidence of ongoing CPD
- Chartered Engineer or Chartered Scientist
- Member of Professional Institute
- Detailed understanding of the medical device regulatory environment (including Medical Device Regulations and ISO14971)
- Detailed understanding of Quality Systems and their application to medical device manufacture and management (ISO 9001 and ISO 13485)
Experience
Essential
- Significant experience of a scientific healthcare environment
- Significant experience of participating in, leading discussion and taking minutes at committees involving complex scientific principles and information
- Significant experience of co-ordinating complex projects; use of associated tools, managing timelines, co-ordinating people
- Significant experience of co-ordinating complex projects; use of associated tools, managing timelines, co-ordinating people
Skills and Abilities
Essential
- Experience of a wide variety of computing systems and application packages
Desirable
- Knowledge of the use of desktop application software for management of a Quality Management System
Values
Essential
- Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication
Essential
- Ability to present information effectively to senior clinicians and Trust managers
- Ability to chair meetings effectively
- Ability to produce accurate technical documentation and to write accurate, concise reports and proposals
Personal and People Development
Essential
- Ability to manage complex technical projects
- Ability to organize and collate complex information and to analyze and re-present it.
- Ability to lead multi-disciplinary teams
- Ability to manage change
- Ability to investigate and solve highly complex novel problems independently, with confidence
- Ability to work as one of a team
- Ability to negotiate solutions to problems where conflicting views exist
- Systematic and logical approach to prboloem-solving
- Great attention to detail
- Full appreciation of patient confidentiality issues
Person Specification
Knowledge and Qualifications
Essential
- First and Higher Degrees in a Physical Science or equivalent subject (or equivalent)
- State Registration as a Clinical Scientist (or eligible to register with evidence of commitment to complete registration with HCPC)
- Evidence of ongoing CPD
- Chartered Engineer or Chartered Scientist
- Member of Professional Institute
- Detailed understanding of the medical device regulatory environment (including Medical Device Regulations and ISO14971)
- Detailed understanding of Quality Systems and their application to medical device manufacture and management (ISO 9001 and ISO 13485)
Experience
Essential
- Significant experience of a scientific healthcare environment
- Significant experience of participating in, leading discussion and taking minutes at committees involving complex scientific principles and information
- Significant experience of co-ordinating complex projects; use of associated tools, managing timelines, co-ordinating people
- Significant experience of co-ordinating complex projects; use of associated tools, managing timelines, co-ordinating people
Skills and Abilities
Essential
- Experience of a wide variety of computing systems and application packages
Desirable
- Knowledge of the use of desktop application software for management of a Quality Management System
Values
Essential
- Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication
Essential
- Ability to present information effectively to senior clinicians and Trust managers
- Ability to chair meetings effectively
- Ability to produce accurate technical documentation and to write accurate, concise reports and proposals
Personal and People Development
Essential
- Ability to manage complex technical projects
- Ability to organize and collate complex information and to analyze and re-present it.
- Ability to lead multi-disciplinary teams
- Ability to manage change
- Ability to investigate and solve highly complex novel problems independently, with confidence
- Ability to work as one of a team
- Ability to negotiate solutions to problems where conflicting views exist
- Systematic and logical approach to prboloem-solving
- Great attention to detail
- Full appreciation of patient confidentiality issues
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
