Regulatory Borderline Specialist

3 weeks ago

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

Position Overview

The Medicines and Healthcare Products Regulatory Agency is looking for a Regulatory Borderline Specialist to be part of the Authorisation Lifecycle subgroup within the Healthcare Quality & Access division.

This is a full-time position on a 12-month Fixed Term contract, primarily based in London. Please note that this role is exclusively available for candidates eligible to work in the UK.

As part of our commitment to fostering a collaborative work environment, we are implementing a flexible hybrid working model, requiring a minimum of 8 days per month on-site. Attendance may vary based on business needs, with potential increases up to 12 days per month, while the remainder of the time can be worked remotely or in the office.

About the Agency

The MHRA is dedicated to evolving into a world-class regulatory body, focusing on making informed benefit-risk assessments to achieve optimal patient outcomes.

The Healthcare Quality and Access portfolio aims to enhance quality and critically evaluate benefits and risks to facilitate sound decisions regarding healthcare access, including expedited access pathways. The Authorisation Lifecycle function plays a crucial role in supporting the frontline HQA group, encompassing data assurance, quality management, and high-volume certification processes.

Key Responsibilities

  • Evaluate complaints regarding products on the UK market that may require classification as medicinal products or medical devices.
  • Ascertain whether a product meets the legal definition of a medicinal product and initiate necessary 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, including the implications of relevant case law.
  • Gain expertise in regulating emerging areas such as software in medical devices, ensuring accurate classification under Medical Devices Regulation.

Candidate Profile

The ideal candidate will possess a degree in a life science or nutritional field, or have significant experience in a relevant regulatory capacity. Strong analytical skills are essential for interpreting complex documents and applying legal principles to casework. Exceptional verbal, written, and presentation skills are required to effectively represent the Agency both domestically and internationally.

Strong organizational abilities and the capacity to perform under pressure while meeting tight deadlines are crucial. The successful candidate will demonstrate a proactive approach to relationship-building and collaboration within a multidisciplinary team environment.

Benefits

  • Competitive salary with contributions towards a Civil Service Defined Benefit Pension scheme.
  • Generous annual leave policy, starting at 25 days and increasing with service.
  • Occupational Sick Pay scheme with increasing benefits based on tenure.
  • Flexible working arrangements to support work-life balance.
  • Access to various employee assistance programs and development opportunities.

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