Medicines and Healthcare Products Regulatory Agency

Head of Medical Devices

Information:

This job is now closed

Job summary

We are seeking aproactive, confidentand enthusiasticHead of Medical Devicesto join ourInnovation AcceleratorfunctioninScientific Research & Innovationgroup. This is afull-timeopportunityon afixed-term/loan/secondment basis until 31stMarch 2025.

The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU and/or our South Mimms, Hertfordshire site. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

TO BE CONSIDERED FOR THIS PLEASE, PLEASE APPLY ON MHRA WEBSITE (http://lhrc1a.rfer.us/MHRAFAD1Fn).

ONLY APPLICATIONS RECEIVED ON MHRA WEBSITE WILL BE CONSIDERED

Main duties of the job

The post holder will support the Head of Innovative Access Pathways in working towards a single integrated access pathway, seeking to map out how the Agency and its partners can provide support for the integration of medical devices and therapeutics to deliver innovative solutions for complete patient care. The post holder will input medical devices regulatory expertise into the development and implementation of the pathway.

The successful candidate will work in a matrix model across the Agency with experts in Healthcare Quality and Access, Safety and Surveillance, Science, Research and Innovation and Partnerships to deliver a comprehensive world leading innovative access pathway.

About us

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Science, Research, and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

The Innovation Accelerator (IA) provides innovators access to the Agencys scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more dynamically with an enhanced advice and signposting service.

Details

Date posted

24 July 2023

Pay scheme

Other

Salary

£67,158 a year + benefits

Contract

Fixed term

Duration

18 months

Working pattern

Full-time

Reference number

K0015-REG003

Job locations

10 South Colonnade

Canary Wharf

London

E14 4PU


N I B S C

Blanche Lane

South Mimms

Potters Bar

Hertfordshire

EN6 3QG


Job description

Job responsibilities

Key responsibilities:

Lead a team of regulatory experts including; a software and Artificial Intelligence specialist, an In Vitro Diagnostics specialist, and an Implantables specialist.

As an integral part of the IDAP team the role will include providing expert advice and input into the planning of the IDAP. Determine how the Agency and its partners can provide support to an integrated system encompassing medical devices and therapeutics to deliver innovative solutions for complete patient care.

Provide expert input into the selection of devices to be included in the IDAP pilot.

Lead the Target Development Profile Meeting and a suite of tools for companies accepted into the IDAP and the pilot scheme.

Job description

Job responsibilities

Key responsibilities:

Lead a team of regulatory experts including; a software and Artificial Intelligence specialist, an In Vitro Diagnostics specialist, and an Implantables specialist.

As an integral part of the IDAP team the role will include providing expert advice and input into the planning of the IDAP. Determine how the Agency and its partners can provide support to an integrated system encompassing medical devices and therapeutics to deliver innovative solutions for complete patient care.

Provide expert input into the selection of devices to be included in the IDAP pilot.

Lead the Target Development Profile Meeting and a suite of tools for companies accepted into the IDAP and the pilot scheme.

Person Specification

Experience

Essential

  • Our successful candidate will have significant and highly relevant demonstrable experience of medical devices and regulatory science as well as substantial experience working in a regulatory environment. You will have minimum degree and equivalent of a Ph.D. in a Science or clinically relevant qualification and in-depth knowledge of regulation and guidance on Medical Devices. You will also have previous experience relevant to delivering advice and strategy and awareness as well as knowledge of Quality Management Systems.
Person Specification

Experience

Essential

  • Our successful candidate will have significant and highly relevant demonstrable experience of medical devices and regulatory science as well as substantial experience working in a regulatory environment. You will have minimum degree and equivalent of a Ph.D. in a Science or clinically relevant qualification and in-depth knowledge of regulation and guidance on Medical Devices. You will also have previous experience relevant to delivering advice and strategy and awareness as well as knowledge of Quality Management Systems.

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.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

10 South Colonnade

Canary Wharf

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

10 South Colonnade

Canary Wharf

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer contact details

For questions about the job, contact:

Recruitment Team

Careers@mhra.gov.uk

Details

Date posted

24 July 2023

Pay scheme

Other

Salary

£67,158 a year + benefits

Contract

Fixed term

Duration

18 months

Working pattern

Full-time

Reference number

K0015-REG003

Job locations

10 South Colonnade

Canary Wharf

London

E14 4PU


N I B S C

Blanche Lane

South Mimms

Potters Bar

Hertfordshire

EN6 3QG


Supporting documents

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