Global Clinical Evaluation Lead (EU MDR Expert)

CORIN LIMITED; England; Presencial; GBP 55 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

25 days holiday plus bank holidays

Excellent pension 6% to 9.7% after 18m

Life assurance

Private medical insurance with BUPA

Free annual eye tests and flu vaccines

Employee referral program

Resumo da oferta

CORIN LIMITED is seeking an experienced Global Clinical Evaluation Lead to drive the development and maintenance of clinical evaluation and post‑market documentation for a global medical device portfolio. You will coordinate Clinical Evaluation Plans and Reports, PMCF plans, SSCP, and literature activities, working with Product Core Teams and regulatory partners across EU, USA, and Asia.

The role requires a strong regulatory background, advanced scientific degree, and at least 3 years in medical

Qualificações

• Advanced scientific degree required.
• Minimum 3 years in Medical Devices or Pharmaceuticals.
• Proven ability to analyse and summarise clinical data for stakeholders.
• Strong understanding of EU MDR and regulatory frameworks.
• Experience literature searches and critical appraisals.
• Ability to interpret clinical study results and data analyses.
• Excellent written and verbal communication with internal/external stakeholders.
• Strong problem-solving with multi-priority management.

Responsabilidades

• Lead preparation and finalisation of clinical evaluations and documentation per EU MDR.
• Collaborate with external clinical evaluation partners and governance meetings.
• Coordinate responses to Notified Bodies for MDR submissions.
• Oversee MDR deliverables including CEPs, CERs, PMCF plans/reports, and SSCP.
• Support global PMS, PSURs, and benefit‑risk assessments.

Conhecimentos

Regulatory knowledge

Clinical data interpretation

Stakeholder management

Communication skills

Formação académica

PhD / MSc / MD or BS/BA in sciences

Descrição da oferta de emprego

CORIN LIMITED is seeking an experienced Global Clinical Evaluation Lead to drive the development and maintenance of clinical evaluation and post‑market documentation for a global medical device portfolio. You will coordinate Clinical Evaluation Plans and Reports, PMCF plans, SSCP, and literature activities, working with Product Core Teams and regulatory partners across EU, USA, and Asia.

The role requires a strong regulatory background, advanced scientific degree, and at least 3 years in medical