Global Clinical Evaluation Lead - Remote & MDR Expert

Corin Group

England

Hybrid

GBP 55,000 - 65,000

Full time

9 days ago

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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

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.

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