Global Clinical Evaluation Lead

We are seeking an experienced Global Clinical Evaluation Lead to oversee the development and maintenance of clinical evaluation and post-market clinical documentation across our global medical device portfolio. This is a pivotal role supporting regulatory compliance under EU MDR, global market access, and post-market surveillance activities. The Global Clinical Evaluation Lead will be responsible for driving high-quality Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), PMCF Plans and Reports, SSCPs, and associated literature activities, while coordinating a wide network of internal and external stakeholders. The role works closely with Product Core Teams (PCTs), clinical study teams, regulatory partners, and notified bodies, and acts as a key clinical subject-matter expert across the business. What you'll do

• Lead and oversee the preparation, review, and finalisation of clinical evaluations and associated documentation in compliance with EU MDR requirements
• Manage and collaborate closely with external clinical evaluation partners, including training, regular governance meetings, and timeline management
• Prepare and coordinate responses to clinical review questions from Notified Bodies to support product submissions and certifications
• Review and approve MDR deliverables including:
• Clinical Evaluation Plans and Reports
• PMCF Plans and PMCF Evaluation Reports
• Literature searches and critical appraisals
• Summary of Safety and Clinical Performance (SSCP)
• Contribute to global post-market and reimbursement-related activities across multiple markets, including EU, USA, Australia, Japan, and other international regions
• Act as the clinical representative at annual Post-Market Surveillance (PMS) meetings, providing expert input into PMS plans, PSURs, and benefit-risk assessments
• Participate in Product Core Team (PCT) meetings, advising on pre- and post-market clinical strategy and regulatory requirements for new product registrations and renewals
• Work closely with data management and clinical study teams to ensure timely delivery of clinical data inputs, escalating risks to timelines where necessary
• Support interpretation and reporting of clinical investigation results (pre- and post-market) for regulatory submissions and internal decision-making
• Serve as a clinical SME to internal teams including R&D, Marketing, and Regulatory Affairs, as well as external regulators when required
  
  You will be a highly organised and detail-driven clinical professional with strong regulatory knowledge and the ability to manage complex documentation across multiple products and markets.
What you'll bring
• Advanced scientific degree (e.g. PhD, MSc), MD, or BS/BA in sciences or nursing, or equivalent combination of education and experience
• Minimum 3 years' industry experience within Medical Devices or Pharmaceuticals
• Proven experience analysing, interpreting, and summarising clinical data for internal and external stakeholders
• Strong understanding of European Medical Device Directive (MDD) and EU MDR
• Experience conducting and reviewing literature searches and appraisals
• Ability to interpret clinical study results and data analyses
• Excellent written and verbal communication skills, with confidence engaging internal and external stakeholders
• Strong problem-solving skills, high attention to detail, and the ability to manage multiple priorities to deadline
Desirable
• Experience with PMCF and/or Post-Market Surveillance (PMS) planning
• Experience supporting regulatory submissions using Real-World Evidence (RWE)
• Familiarity with global regulatory environments outside the EU
  
  You'll play a key role in shaping the clinical and regulatory strategy of a global medical device portfolio, working with cross-functional experts in a collaborative and supportive environment that values scientific excellence and patient safety.
What's in it for you:
• A competitive salary £55,000 - £65,000 dependent on experience and a discretionary annual bonus of 7.5%
• 25 days holiday plus bank holidays
• Excellent pension - starts at 6%, going up to 9.7% after 18 months.
• Life assurance - Six times your basic salary
• Private medical insurance with BUPA for you and your family
• Free annual eye tests and flu vaccinations
• Employee referral program where you can earn from £1,000 for each successful hire you recommend