Job responsibilities
Role Description
Job Title
Innovative IVDs and General Medical Devices Lead
Pay Grade
G6
Location
Canary Wharf, London
Hours
37 hours per week (excluding lunch break)
Reports to
Head of IVDs and General Medical Devices
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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
The agency consists of Corporate, Partnerships, Transformation, Governance, Communications & Engagement, Scientific Research & Innovation, Healthcare Quality & Access, Safety & Surveillance and Technology groups.
About the Division
The Innovative Devices function is leading on the development of a new regulatory framework for the UK, which protects patient safety whilst enabling innovation. It also works to improve pre-market support for medical device manufacturers and developers and facilitate a smooth passage to market access through improved regulation and guidance along with tailored support for innovative products across med-tech, diagnostics and digital, or where there is higher associated risk. The function will ensure that the UK has supply of new and advancing medical devices to include software as a medical device, novel implantable devices and diagnostics and play a significant role in developing the new Regulatory Framework for Medical Devices
Role Purpose
The post holder will ensure that timely and appropriate team leadership and specialist input is provided to the development and implementation of the new regulations to ensure they are fit for purpose, working in collaboration with colleagues across the Agency, in particular in the Partnerships portfolio, Government Legal Department and Department of Health and Social Care. This will include Medical Devices Regulation in Northern Ireland, leading interactions with DHSC and external stakeholders on how the MHRA fulfils its regulatory duties in Northern Ireland.
The post holder will lead a team of specialists, setting clear objectives for that team and supporting them to deliver. The post holder will have a key focus on review and development of a strategy for IVDs and implantable devices, ensuring these products are regulated accordingly to their risk profile and that we clearly address the recommendations in the Independent Medicines and Medical devices safety review (IMMDSR).
You will actively contribute towards ongoing improvement and a positive working environment throughout the wider Agency.
Key responsibilities and results areas
Leadership and management
- The post holder will lead a team of up to 10 people, creating a sense of purpose for the team through highlighting connections between our work and the impact on patients and the public.
- They will inspire their team to be fully engaged in their work. Deliver difficult or complex messages with decisiveness, clarity and sensitivity, being persuasive when required. Promote diversity, inclusion and equality of opportunity, respecting difference and external experiences. Provide support, guidance and coaching for the team. Show commitment to personal development. Promote effective individual and team performance.
- Ensure team members have clear deliverables for which they are accountable: Empower them to make decisions, innovate and challenge without being blamed. Be self-aware and role-model continuous self-learning and development.
- Lead and drive a complex activities with competing priorities with multiple partners and stakeholders and delivering at pace.
- Provide insight and leadership to achieve the MHRAs business plan and corporate objectives.
Service delivery
- The post holder will be the senior lead for the Coronavirus Test Devices Approvals (CDTA) process, responsible for delivery under the current scheme including financial management, as well as supporting the Head of IVDs and General Medical Devices to design and implement sustainable arrangements for Coronavirus testing.
- The post holder and their team will own deliverables in the Med Tech Regulatory Reform plan and be accountable for on time delivery.
Support the head of IVDs and General Medical Devices in the development and publication of a strategy for IVDs and implantables including Neurotech, in line with the response to the IMMDSR.
- Work to unify workstreams, spot opportunities and break down silos, manage interdependencies to ensure an end-to-end delivery view.
Drive effective governance, planning and execution, setting appropriate delivery methodologies and priorities to manage implementation and change effectively.
The job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the postholder.
Person Specification
Important Candidate information:
The Civil Service recently launched a new recruitment framework called Success Profiles, which has replaced the Civil Service Competency Framework.
Success Profiles are made up of 5 elements: Ability, Behaviours, Experience, Technical, Strengths but it is unlikely that you will be assessed against all 5.
Behaviours, Experience and Technical elements will be assessed through your application form, in the first instance.
Success Profile
Criteria
Method of assessment: A-Application, T-Test, I-Interview, P-Presentation
Behaviour
Communicating & Influencing - highly developed interpersonal and influencing skills and the credibility to build excellent relationships and networks with key stakeholders across organisational boundaries, taking a collaborative approach. Using effective communication methods to deliver difficult messages or objectives with clarity and sensitivity, being persuasive when needed.
A, I
Behaviour
Changing & Improving - a flexible and adaptable leader with the ability to support, guidance and coaching others through change whilst maintaining strong governance and processes. Compliance with statutory and regulatory frameworks. Consider the full impact of implementing changes on culture, structure, morale and the impacts on the diverse range of end users, including accessibility needs.
A, P
Behaviour
Leadership - a strong and inclusive corporate and team leader, confident in both people leadership and policy development in an operational context, with the ability to empower and motivate others in a dynamic environment and across organisational boundaries and create cultures of high performance and continuous improvement, with an engaging, adaptable leadership style. Inspire and motivate team members to be fully engaged in their work in fulfilling their roles.
A, I
Experience
Developing and implementing complex policy involving diverse stakeholders.
A, I
Experience
Preference for those with operational experience working in a regulatory environment and in healthcare at a policy, operational or front-line level.
A
Experience
The ideal candidate will have experience of working with Medical Device Regulations or IVD regulations in the UK or EU. Strong understanding of compliance with statutory and regulatory frameworks.
A
Technical
Bachelors degree in a relevant discipline e.g. science, engineering, medicine or equivalent experience developed through previous roles.
A
Technical
Excellent written and oral communication skills including grammatical/technical writing skills.
A, P
Strengths
Influencer - articulating the rationale to gain agreement.
I
The Civil Service Code
These core values support good government and ensure the achievement of the highest possible standards in all that the Civil Service does. You can find out more about our values, standards of behaviour and rights and responsibilities in The Civil Service Code.
The code is reflected in the Agencys values,which state that we will strive to be:
Agency Values
We focus outwards on patients and public
We work together with respect.
We take responsibility and are accountable
Civil Service Values
Integrity
Putting the obligations of public service above your own personal interests
Honesty
Being truthful and open
Objectivity
Basing your advice and decisions on rigorous analysis of the evidence
Impartiality
Acting solely according to the merits of the case and serving equally well governments of different political persuasions
