Regulatory Affairs Manager (Medtech)

TL;DR

Regulatory Affairs Manager (Medtech): Developing and executing regulatory strategies for clinical trials and expanded access programs with an accent on global compliance and health authority submissions. Focus on navigating complex regulatory pathways across the US and Europe to enable timely medicine access for patients.

Location: Remote, UK or Hybrid in Chiswick, London, UK

Company

hirify.global is a mission-driven organization providing clinical trial services and expanded access programs to help patients gain early access to medicines worldwide.

What you will do

• Serve as the primary regulatory contact for Clinical Trials, EAP, CUP, and PA-NPP programs across the US, Europe, and Rest of World.
• Develop and implement regulatory strategies to ensure compliant and timely product access.
• Lead the preparation, compilation, and submission of regulatory applications to Health Authorities.
• Oversee domestic licenses in the US, UK, and Ireland, collaborating with Quality and Supply Chain teams.
• Maintain accurate regulatory documentation, intelligence trackers, and project databases.
• Partner cross-functionally with Medical Affairs, Clinical Operations, and Pharmacovigilance to support project execution.

Requirements

• Bachelor's degree in legal, life sciences, or a scientific equivalent.
• 5+ years of broad regulatory experience.
• Familiarity with global regulatory frameworks, specifically EU and FDA regulations.
• Experience in developing regulatory strategies and communicating risks to stakeholders.
• Must be based in the UK.
• Strong analytical skills and proficiency in Microsoft Office.

Nice to have

• Expertise in unlicensed supply, such as Expanded Access, Compassionate Use, or Named Patient programs.

Culture & Benefits

• Private healthcare insurance and long-term illness cover.
• Salary sacrifice pension and death in service cover.
• Paid maternity and paternity leave.
• Annual leave and a dedicated volunteer day.
• Commitment to diversity, equity, and inclusion (DEI) values.