Senior Regulatory Affairs Specialist

6 days ago

London, Greater London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

We are currently looking for 3
Senior Regulatory Affairs Specialists (Auditors) to join our
Standards and Compliance team within the
Healthcare Quality & Access group.

These are
full-time opportunities on a
permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London or remotely. 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.

Who are we?


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 objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.

It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.


The Standards & Compliance function will enable innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Inspectorate, the Inspection Action Group and Devices Audit and Compliance.


What's the role?

Key responsibilities:

  • Acting as a Team Leader & Member for onsite audits of Approved Bodies and team leader on MHRA witnessed audits of Approved Bodies and direct audits of manufacturers (including economic operators).
  • Support the team with monitoring of the marketplace, reviewing available sources of information and supporting campaigns to build into MHRA's proactive Market Surveillance Plan.
  • Provide strategic input at global meetings working with colleagues and stakeholders develop clear strategic goals for continuous improvement of the system and its management.
  • Provision of regulatory advice regarding the implementation and interpretation of the current and future medical devices regulatory framework and associated UK legislation.

Who are we looking for?
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification

The selection process:

-
Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
-
Presentation as part of your interview. Details will be provided when you reach this stage.


Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role.

Closing date: 25/06/2023

Interview Date: 03/07/2023

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1 Horse Guards Road

London

SW1A 2HQ

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