Be at the heart of actionFly remote-controlled drones into enemy territory to gather vital information.

Apply Now

Director, Regulatory Affairs Opthalmology

Barrington James
Horley
2 days ago
Create job alert
Job Description

The Director of Regulatory Affairs will lead the regulatory function and play a central role in shaping and executing global regulatory strategies for our ophthalmology assets.


Key Responsibilities
Regulatory Leadership & Strategy

Define and lead global regulatory strategy for ophthalmology programs from Phase II through Phase III and registration.


Serve as the primary regulatory contact with EMA, FDA, Swissmedic and other health authorities.


Develop and maintain regulatory roadmaps aligning cross‑functional teams on timelines and deliverables.


Execution & Submissions

Oversee the preparation, review, and submission of key regulatory documents (INDs / CTAs, Scientific Advice, Briefing Books, PIPs, Orphan Designation, BLA / NDA / MAA modules).


Ensure timely responses to health authority queries and manage interactions / meetings with agencies.


Lead regulatory risk assessments and provide mitigation strategies throughout the product lifecycle.


Team Leadership

Manage, mentor, and develop a team of regulatory professionals.


Build scalable regulatory capabilities suitable for a growing biotech organization.


Foster a collaborative, accountable, and solution‑oriented culture.


Cross‑functional Collaboration

Partner with Clinical, CMC, Nonclinical, and Quality teams to ensure regulatory alignment across all development activities.


Provide regulatory input into study protocols, development plans, and labeling strategies.


Support due diligence activities and business development opportunities as needed.


Qualifications & Experience

Advanced degree in life sciences, pharmacy or related field; higher degree (PhD, PharmD, MSc) preferred.


10 years experience in Regulatory Affairs with significant exposure to ophthalmology or related therapeutic areas.


Proven track record of leading regulatory strategy and interactions with EMA and FDA particularly from Phase II through pivotal Phase III and registration.


Strong experience in authoring and managing global regulatory submissions (IND / CTA / MAA, NDA / BLA).


Prior leadership / line management experience – able to motivate and develop a high‑performing regulatory team.


Experience in small to mid‑sized biotech or pharma environment with hands‑on strategic and operational responsibilities.


Excellent knowledge of ICH, EU, US and Swiss regulatory requirements.


Strong communication, influencing and leadership skills with ability to work in a fast‑paced entrepreneurial setting.


Based in Geneva or Lausanne area with a hybrid working model (on‑site 23 days / week).


Required Experience

Director.


Key Skills

  • Proofreading
  • Adobe Acrobat
  • FDA Regulations
  • Manufacturing & Controls
  • Biotechnology
  • Clinical Trials
  • Research & Development
  • GLP
  • cGMP
  • Product Development
  • Chemistry
  • Writing Skills

Employment Type

Full‑Time


Experience

Years


Vacancy

1


#J-18808-Ljbffr

Related Jobs

View all jobs

Director, Global Regulatory Affairs - Ophthalmology

Director, Regulatory Affairs (Digital Medical Devices)

Director, Regulatory Affairs (Digital Medical Devices)

Director, Regulatory Affairs (Digital Medical Devices)

Director, Regulatory Affairs Labeling

Director, Regulatory Affairs, Pre-Market

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Medical Technology Recruitment Trends 2025 (UK): What Job Seekers Need To Know About Today’s Hiring Process

Summary: UK medical technology hiring has shifted from title‑led CV screens to capability‑driven assessments that emphasise regulatory‑aware product delivery (QMS, ISO 13485), software lifecycle & risk (IEC 62304/14971), usability (IEC 62366), clinical & regulatory strategy (MDR/UKCA), device cyber security & privacy, and measurable patient/clinical and commercial impact. This guide explains what’s changed, what to expect in interviews & how to prepare—especially for SaMD engineers, AI/ML in medical devices, product & quality engineers, regulatory/clinical affairs specialists, validation/verification, manufacturing/operations, and digital health roles. Who this is for: Software/firmware engineers in medtech, SaMD/AI engineers, systems & verification engineers, quality & regulatory affairs (QARA), clinical evaluation/PMCF specialists, human factors engineers, medical device cyber security & privacy, test/validation, manufacturing & operations, field/service engineers, and medtech product managers in the UK.

Why Medical Technology Careers in the UK Are Becoming More Multidisciplinary

Medical technology (medtech) is transforming healthcare in the UK — from wearable sensors to AI diagnostic tools, from surgical robots to telemedicine platforms. Advances in hardware, software, data and connectivity are enabling more personalized, efficient and accessible care. But with great power comes great responsibility. As medical devices and health technologies enter hospitals, clinics and consumers’ homes, professionals in this domain must master much more than engineering and algorithms. They must also understand law, ethics, psychology, linguistics & design. That is, medtech careers are now deeply multidisciplinary. In this article, we explore why medical technology careers in the UK are becoming more multidisciplinary, how these five allied fields now intersect with medtech work, and what job-seekers and employers should do to succeed in this evolving ecosystem.

Medical Technology Team Structures Explained: Who Does What in a Modern MedTech Department

Medical technology (MedTech) spans everything from wearable health devices and surgical robots to diagnostic imaging, in-vitro diagnostics (IVD), digital therapeutics, AI-driven triage, and Class I–III medical devices. In the UK, the sector touches NHS care pathways, private providers, and global markets—with stringent expectations for safety, clinical evidence, cybersecurity, and data privacy. As ventures scale from prototype to regulated product, clear team structures become the difference between promising pilots and licensed, market-ready devices. Whether you’re hiring your first clinical specialist or applying for a role in QA/RA, this guide explains who does what in a modern MedTech department, how functions collaborate across the product lifecycle, UK-typical skill sets and salaries, common pitfalls, and best practices for building a resilient team.