Global Clinical Evaluation Specialist

Location: Cirencester / Hybrid

About the Role

We are seeking an experienced Global Clinical Evaluation Specialist 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. You'll 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.

About You

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 5 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.

Why Join Us

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 and a discretionary annual bonus.
• 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 up to £1,000 for each successful hire you recommend.