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Regulatory Affairs Lead
2 months ago
Job Overview
The Medicines and Healthcare Products Regulatory Agency is looking for a Borderline Lead 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 designated for UK-based candidates only.
Government entities are moving towards a policy of a minimum 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 and engagement with partners and stakeholders essential for the Agency's operations. Depending on the role's requirements, this may increase to 12 days a month, with the remaining time being worked remotely or in the office. Certain positions may necessitate more frequent on-site presence.
About Us
The MHRA is evolving to become a premier regulatory body, focusing on making informed benefit-risk assessments and achieving optimal outcomes for patients.
The Healthcare Quality and Access portfolio aims to enhance quality and critically evaluate benefits and risks to support sound decisions regarding healthcare access, including expedited access pathways. The Authorisation Lifecycle function plays a pivotal role in delivering the frontline HQA group, encompassing data assurance, quality management, high-volume certification tasks, and support for frontline operations.
Key Responsibilities
- Evaluate complaints received by the MHRA 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 take necessary actions to ensure compliance with applicable legislation.
- Determine if a product qualifies as a medical device, classify its risk appropriately, and assist the Devices Compliance team in ensuring compliance with medical device regulations.
- Develop a comprehensive understanding of regulatory areas that intersect with medicinal products and medical devices, including the implications of relevant case law.
- Gain expertise in the regulation of emerging areas such as software in medical devices and accurately identify which products fall under the medical device definition in accordance with Medical Devices Regulation.
Candidate Profile
The ideal candidate will possess a degree in a life science or nutritional discipline, or have significant experience in a relevant regulatory capacity. You should be adept at distilling key information from complex documents and applying legal principles to casework. Strong verbal, written, and presentation skills are essential for effectively representing the Agency both domestically and internationally. Excellent organizational skills and the ability to work under pressure while maintaining professionalism are crucial. You should also be capable of fostering relationships and collaborating successfully within a multidisciplinary team environment.
Benefits
In addition to a competitive salary, the Medicines and Healthcare Products Regulatory Agency offers a comprehensive benefits package, including:
- 25 days of annual leave, increasing with years of service, plus 8 bank holidays.
- Occupational Sick Pay scheme.
- Flexible working arrangements to promote a healthy work-life balance.
- Access to various employee assistance programs and development opportunities.
