Global Clinical Evaluation Lead

Corin Group; England; Hybrid; GBP 55,000 - 65,000; Full time

Benefits offered by this job

Competitive salary

Annual discretionary bonus

25 days holiday

Pension plan

Life assurance

Private medical insurance

Eye tests & flu vaccinations

Employee referral program

Job summary

Corin Group seeks a Global Clinical Evaluation Lead to oversee CEPs, CERs, PMCF plans/reports, and SSCPs across a global medical device portfolio. This role supports EU MDR compliance, global market access, and post-market surveillance with hybrid/remote work and travel to Cirencester.

You will lead cross-functional teams, coordinate external partners, and act as clinical SME for R&D, Regulatory Affairs, and stakeholders in EU, USA, Australia, and Japan.

Qualifications

• Minimum 3 years’ industry experience in Medical Devices or Pharmaceuticals.
• Strong regulatory knowledge of EU MDR and MDD.
• Experience conducting literature searches and appraisals.
• Ability to interpret clinical study results and data analyses.
• Excellent written and verbal communication and stakeholder engagement.

Responsibilities

• Lead preparation and finalisation of clinical evaluations and documentation per EU MDR requirements.
• Collaborate with external clinical evaluation partners and governance meetings.
• Coordinate responses to clinical review questions from Notified Bodies.
• Review MDR deliverables: CEPs, CERs, PMCP Plans/Reports, literature searches and SSCP.
• Contribute to post-market and reimbursement activities across EU, USA, Australia, Japan.
• Represent clinical input at PMS meetings and advise on product registrations and renewals.
• Work with data management and clinical study teams to ensure timely data inputs.
• Support interpretation of clinical investigation results for regulatory submissions.
• Serve as clinical SME to R&D, Marketing, Regulatory Affairs and regulators.

Skills

Regulatory knowledge

Clinical data analysis

Communication skills

Project management

Attention to detail

Stakeholder engagement

Multitasking

Data management

Education

PhD

MSc

MD

BS/BA in sciences or nursing

Job description

Global Clinical Evaluation Lead

Location: Hybrid/Remote (travel to Cirencester)

About the Role

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

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 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

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 £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