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About the Role

The role will strategically lead in vitro diagnostic (IVD) device assessments and service improvements within the Clinical Investigations and Trials function.

Responsibilities

• Identify and articulate the overarching strategy for IVD assessments in clinical trial studies.
• Oversee externally facing engagements with clinical trial sponsors for service coordination, performance, and issue resolutions.
• Oversee the execution of the strategy on improvements in assessments and communications, including systems, tools, quality management, business planning, financial reporting, and change management, ensuring all activities meet the highest professional standards and service performance.
• Establish the governance for IVD assessments and lead on the operational improvements of the service.

Requirements

• Educated to degree level in a relevant discipline (e.g. Biochemistry, medicine).
• Experience in IVD policy, product development, or conformity assessment.
• Experience working in a clinical, medical, or toxicology laboratory.
• Prior experience with manufacturing and/or research and development of an IVD medical device.
• Expert understanding of UK MDR, EU IVDR, and EU MDR, and Clinical trial regulations, particularly clinical evidence for IVD medical devices.
• Experience with leading and running a complex regulated assessment service, including the implementation of continuous improvement initiatives.
• Experience with communicating a vision, direction, plan, and key performance measures to senior stakeholders.
• Led a leadership team of at least 4 direct reports with a team to deliver against objectives and strategy.
• Minimum of bachelor’s degree in a medicine, science, engineering fields of study or equivalent experience developed through previous roles.

Skills

• Leadership
• Communicating & Influencing
• Working Together

Location

• 10 South Colonnade, Canary Wharf London, E14 4PU

Work Type

• Full-time
• Permanent
• Hybrid

Experience Level

• Senior

Education Level

• Degree level

About the Company

• 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, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.

Equal Opportunity

• Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules.
• Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks.
• People working with government assets must complete basic personnel security standard checks.
• Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance.
• Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD).
• A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.
• Any move to the MHRA from another employer will mean you can no longer access childcare vouchers.
• Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms.
• Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater.
• The individual will not retain any allowances paid by the former department/Agency, unless there are special circumstances, such as a reserved right to those allowances on transfer.
• Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements.
• In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition.