- Hybrid working - our approach is to be in the office or on client site a minimum of 2 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client site.
- This role can be based at either our London Victoria or Melbourn office
Within our Life Sciences work, we support global organisations to design, develop and bring to market innovative products that improve patient outcomes. This includes complex combination products across pharmaceuticals, medical devices, biologics and advanced therapies.
We are seeking an experienced Combination Product Quality Specialist to support the development and life‑cycle management of combination products (drug–device, biologic–device and advanced therapy–device).
You will play a pivotal role in helping our clients navigate regulatory complexity, embed robust quality systems, and ensure product safety, compliance and performance from early development through to post‑market. Working as part of multi‑disciplinary project teams, you will bring deep technical expertise alongside strong collaboration and stakeholder engagement skills.
What you’ll do
You’ll apply your quality and regulatory expertise across a broad range of client engagements, including:
Quality assurance and compliance
- Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements.
- Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records, ensuring alignment and traceability across the product life cycle.
- Supporting supplier qualification, audits and gap assessments, ensuring compliance with global regulatory expectations.
Combination product and device‑drug expertise
- Acting as a subject matter expert on drug–device interactions and product integrity considerations.
- Interpreting and overseeing Container Closure Integrity Testing (CCIT) to support sterility and product stability.
- Supporting the design and evaluation of stability and compatibility studies, considering both device and pharmaceutical components under real‑world conditions.
Regulatory and technical strategy
- Interpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‑market phases.
- Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies.
Technology transfer and lifecycle management
- Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments.
- Contributing to process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout.
Risk and post‑market activities
- Leading risk management activities in line with ISO 14971, including hazard analysis, risk evaluation and mitigation strategies.
- Supporting post‑market surveillance, vigilance and complaints investigations, ensuring robust CAPA and documentation.
Project delivery
- Working as part of, or leading, cross‑functional project teams, managing quality deliverables, tracking actions and supporting timely decision‑making.