Director of Regulatory Affairs - Pathogena

Ellison Institute of Technology Oxford; Oxford; On-site; GBP 60,000 - 100,000; Full time

Job description

The Ellison Institute of Technology (EIT) Oxford tackles humanity's greatest challenges by turning science and technology into impactful global solutions. Focused on areas like health, food security, sustainable agriculture, climate change, clean energy, and AI-driven government innovation, EIT Oxford blends groundbreaking research with practical applications to deliver lasting results.

A cornerstone of EIT Oxford's mission is its upcoming 300,000-square-foot research facility at the Oxford Science Park, set to open in 2027. This cutting-edge campus will feature advanced labs, an oncology and preventative care clinic, and collaborative spaces to strengthen its partnership with the University of Oxford. It will also host the Ellison Scholars, driving innovation for societal benefit.

The Pathogen Mission highlights EIT's transformative approach, using Whole Genome Sequencing (WGS) and Oracle's cloud technology to create a global pathogen metagenomics system. This initiative aims to improve diagnostics, provide early epidemic warnings, and guide treatments by profiling antimicrobial resistance. The goal is to deliver certified diagnostic tools for widespread use in labs, hospitals, and public health.

EIT Oxford fosters a culture of collaboration, innovation, and resilience, valuing diverse expertise to drive sustainable solutions to humanity's enduring challenges.

We are seeking a Director of Regulatory Affairs to lead the development and execution of global regulatory and clinical strategies that enable timely approval and compliance of our products and services. This pivotal role involves overseeing regulatory submissions, managing complex projects across multiple jurisdictions, and serving as the primary liaison with regulatory authorities worldwide. Reporting to the Chief Medical Officer and working closely with scientific and product teams, the Director will play a critical role in ensuring our innovations reach the market—and ultimately the patients—who stand to benefit most.

Key Responsibilities:

• Develop and implement global regulatory strategies for IVD diagnostic tools and Software as a Medical Device. (SaMD)
• Lead the preparation, submission and maintenance of regulatory filings to US FDA, EU (IVDR and CE) and other key global markets.
• Ensure products and processes are compliant with all relevant international regulations and standards.
• Collaborate with cross-functional teams to support product development and approvals.
• Monitor changes in regulatory requirements globally and ensure timely updates to processes and documentation.
• Represent the organisation in regulatory meetings and discussions worldwide.
• Provide regulatory input on clinical study designs, protocols, and endpoints to support product claims
• Collaborate with R&D, clinical, and product teams to align development timelines with regulatory requirements
• Ensure compliance with any post-marketing surveillance obligation or reporting requirements.
• Provide leadership and guidance to regulatory affairs teams
  
  
  

Requirements


Qualifications & Experience:

• Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs).
• Minimum of 10 years of experience in regulatory affairs within healthcare, medical devices, pharmaceuticals, or a related field.
• Proven experience of obtaining regulatory approval for IVD product in the US or EU.
• At least 3 years of leadership experience managing regulatory or clinical teams.
• Strong knowledge of U.K., U.S., and international regulatory submission requirements.
• Ability to lead regulatory initiatives and drive process improvements.
• Excellent problem-solving, analytical, and project management skills.
• Strategic thinker with the ability to anticipate regulatory trends and plan proactively
• Highly detail-oriented and organized, capable of managing complex projects and multiple priorities
• Strong communication skills, with the ability to clearly convey regulatory concepts to both technical and non-technical stakeholders
• Collaborative team player who works effectively across departments and disciplines
• Decisive and accountable, able to take ownership of challenges and drive solutions forward
• Resilient and adaptable in a fast-paced, evolving environment
• Deeply committed to ethical standards, compliance, and promoting a culture of integrity
  
  
  

Benefits


We offer the following salary and benefits:

• Salary: Competitive, depending on experience + travel allowance + bonus
• Enhanced holiday pay
• Pension
• Life Assurance
• Income Protection
• Private Medical Insurance
• Hospital Cash Plan
• Therapy Services
• Perk Box
• Electric Car Scheme
  
  
  

Why work for EIT:

At the Ellison Institute, we believe a collaborative, inclusive team is key to our success. We are building a supportive environment where creative risks are encouraged, and everyone feels heard. Valuing emotional intelligence, empathy, respect, and resilience, we encourage people to be curious and to have a shared commitment to excellence. Join us and make an impact!

Terms of Appointment:

• You must have the right to work permanently in the UK with a willingness to travel as necessary
• You will live in, or within easy commuting distance of, Oxford
• There is likelihood that there will be occasional international travel.
• During peak periods, some longer hours may be required and some working across multiple time zones due to the global nature of the programme