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Regulatory Borderline Specialist

2 months ago

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

Position Overview

The Medicines and Healthcare Products Regulatory Agency is in search of a Regulatory Borderline Specialist to contribute to the Authorisation Lifecycle subgroup within the Healthcare Quality & Access division.

This is a full-time role on a 12-month Fixed Term basis, primarily located in London. Please note that this position is restricted to candidates eligible to work in the UK.

Government initiatives are moving towards a minimum of 60% in-office attendance.

We are currently adopting a flexible, hybrid working model, requiring a minimum of 8 days per month on-site to facilitate collaboration with partners and stakeholders essential for the Agency's operations. Depending on the role's requirements, this may increase to 12 days per month, with the remainder of the time being worked remotely or in the office. Certain positions may necessitate more frequent on-site presence.

About the Agency

The MHRA is evolving to become a premier regulatory body, focused on making informed benefit-risk assessments and achieving optimal outcomes for patients.

The Healthcare Quality and Access portfolio aims to enhance quality and rigorously evaluate benefits and risks to support sound decisions regarding healthcare access, including expedited access pathways. The Authorisation Lifecycle function plays a pivotal role in supporting the frontline HQA group, encompassing data assurance, quality control, high-volume certification processes, and coordination with frontline operations.

Role Responsibilities

  • Evaluate complaints directed to the MHRA regarding the classification of products on the UK market as medicinal products or medical devices.
  • Ascertain whether a product meets the legal criteria for a medicinal product and initiate necessary regulatory compliance actions.
  • Determine if a product qualifies as a medical device, classify its risk appropriately, and assist the Devices Compliance team in ensuring adherence to medical device regulations.
  • Develop a comprehensive understanding of regulatory intersections between medicinal products and medical devices, and interpret the implications of relevant case law on product classification.
  • Enhance expertise in regulating emerging areas such as software in medical devices, ensuring accurate classification under the Medical Devices Regulation.

Candidate Profile

The ideal candidate will possess a degree in a life science or a related field, or have substantial experience in a relevant regulatory capacity. You should be adept at distilling key information from complex documents and applying legal principles to casework. Exceptional verbal, written, and presentation skills are essential for effectively representing the Agency both domestically and internationally. Strong organizational and planning abilities are required, along with the capacity to work under pressure while maintaining professionalism. The ability to build relationships and collaborate successfully within a multidisciplinary team is crucial.

Benefits

In addition to a competitive salary, the Medicines and Healthcare Products Regulatory Agency offers a comprehensive benefits package, including:

  • Annual Leave: 25 days of annual leave upon entry, increasing by one day for each completed year of service, up to a maximum of 30 days, plus 8 bank holidays.
  • Occupational Sick Pay: Generous sick pay provisions based on length of service.
  • Flexible working arrangements to promote a healthy work-life balance.
  • Access to various employee assistance programs and development opportunities.