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Senior Quality and Regulatory Specialist – Medical Devices

Employer
KINGS COLLEGE LONDON
Location
London (Central), London (Greater)
Salary
£51,974 to £61,021 per annum, including London Weighting Allowance
Closing date
19 May 2024

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Job Details

About us

We are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic.

We welcome applications from individuals with experience in:

  • Regulatory Affairs supporting MedTech start-up organisations
  • Quality Management Implementation
  • Software as a Medical Device

The post holders will be based in the London Institute for Healthcare Engineering (LIHE) part of the School of Biomedical Engineering and Imaging Sciences, King's College London.

About the role

Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide.

The post holders will support a wide variety of research projects in the School and start-up companies as part of our MedTech Venture Builder and Accelerator programmes in the MedTech and Digital Health Hubs to develop new class I to class III medical devices and healthcare technology.

They will operate within the Medical Engineering Quality Management System (QMS), developed to meet the requirements of ISO 13485 and the development of state-of-the-art medical technology, including surgical robotics, active implants, imaging software and AI.

The post holders will be part of a growing Quality and Regulatory Team and provide guidance to project teams on regulatory strategy and planning, quality system procedures, identifying gaps in project information and processes; recommending solutions, and be responsible for developing and maintaining compliant processes and technical documentation that meet the needs of the different stakeholders within and external to the organisation.

This is a full time post (35 Hours per week), and you will be offered a fixed term contract until 30 September 2026.

About You

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

  1. Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
  2. Knowledge and experience applying quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
  3. Experience in the application of design controls and risk management to medical device or SaMD design activities, e.g. writing or reviewing design plans, requirements, hazard analysis, verification and validation protocols and reports.
  4. Ability to understand regulatory needs and provide strategic advice.
  5. Experience of working to quality system procedures.
  6. Experience of preparing and writing standard operating procedures, templates and/or test method instructions.
  7. Experience of project or task prioritisation, able to handle several projects at once and work collaboratively with different teams to agreed deadlines.
  8. Excellent organisational, written and verbal communication skills and ability to troubleshoot.

Desirable criteria

  1. Knowledge and experience of development and testing standards applied to medical devices e.g. ISO 62366, IEC 62304, IEC 60601 series, or ISO 10993 series.
  2. Auditing experience
  3. Experience in preparing regulatory submissions
  4. Experience in working with early-stage companies, where requirements are not clearly defined and where flexibility is needed

Full details of the role and the skills and experience required can be found in the attached job description which is provided on the next page.

Further information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers review your application, please take a look at our ‘How we Recruit’ pages.

Company

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

Company info
Mini-site
KINGS COLLEGE LONDON
Telephone
+(44)02078365454
Location
STRAND
LONDON
WC2R 2LS
GB

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