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About the Role

The Borderline Adviser role assists in determining if a product is a medicinal product or medical device, and its appropriate legal risk classification. This involves researching and providing relevant material to Borderline Leads, and communicating the Agency’s policy to industry, regulators, and stakeholders.

Responsibilities

• Assist in determining if products fall within the legal definition of a medicinal product and take appropriate action for compliance.
• Assist in determining if a product falls within the legal definition of a medical device and its appropriate risk classification, supporting the Devices Compliance team.
• Develop an understanding of regulatory areas bordering medicinal products or medical devices and the impact of case law on borderline product classification.
• Triage enquiries and complaints received into the Borderline inbox, allocate complex requests, and create records for non-urgent cases in SharePoint.

Requirements

• Excellent verbal, written, and presentational communication skills.
• Sound interpersonal skills with proven ability to build relationships and work in a multidisciplinary team.
• Proven ability to gather, interpret, and analyze information for product status decisions.
• Ability to identify key points from complex documents and apply legal principles to casework.
• Working knowledge of medicines, medical device, food, cosmetics, or advertising regulations.
• Interest and awareness of issues affecting healthcare product regulation is desirable.
• Must be a Civil Service employee or employee of accredited non-departmental public bodies (NDPBs) appointed on merit or through an exception.
• Successful candidates must pass a disclosure and barring security check, animal rights and pro-life activism checks, and basic personnel security standard checks.
• Successful candidates may be subject to annual Occupational Health reviews.
• Applicants details held on the Internal Fraud Database (IFD) will result in refusal of employment.
• A candidate is not eligible to apply if an application is made within a 5-year period following dismissal for internal fraud against government.

Skills

• Communication
• Interpersonal skills
• Relationship building
• Teamwork
• Information gathering
• Information interpretation
• Information analysis
• Legal principle application
• Regulatory knowledge (medicines, medical devices, food, cosmetics, advertising)

Location

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

Work Type

• Full-time
• Permanent
• Hybrid

Education Level

• Degree in a life science / nutrition subject area or substantial experience in a relevant regulatory role.

About the Company

• The Medicines and Healthcare products Regulatory Agency enhances and improves 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

• 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.