Clinical Evaluation Specialist

Role & Responsibilities:

• Develop and author clinical evaluation deliverables such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans/reports, Post-Market Clinical Follow-up (PMCF) plans/reports, and Summary of Safety and Clinical Performance (SSCP) reports, in strict compliance with EU MDR 2017/745 and relevant global regulatory standards.
• Critically evaluate and synthesize clinical evidence from various sources including clinical investigations, scientific literature, PMS/PMCF data, and registries. This includes reviewing medical literature, analysing clinical risks, and providing comprehensive benefit-risk assessments for medical devices.
• Collaborate cross-functionally with teams in Regulatory Affairs, R&D, Quality Assurance, Sales, and Marketing to ensure alignment on clinical evaluation project deliverables and support product development, approval, and post-market activities.
• Review and provide feedback on Instructions for Use (IFUs), patient guides, clinical study protocols, and clinical investigation reports to ensure consistency and compliance with regulatory requirements.
• Manage responses to regulatory authorities (e.g., Notified Bodies and Competent Authorities), addressing complex queries related to clinical evaluations and ensuring compliance with EU MDR and other regulatory frameworks.
• Ensure quality and integrity of documentation, maintaining attention to detail, consistency, and adherence to regulations such as ISO 13485, ISO 14155, MEDDEV 2.7/1 Rev 4, and EU MDR 2017/745.
• Support regulatory submissions by providing clinical evidence for product approvals, indication expansions, and ensuring compliance with post-market surveillance and clinical follow-up obligations.
• Stay current with global regulations and standards, including MDR, MEDDEV, and ISO, and effectively communicate the implications of evolving regulatory landscapes to internal stakeholders.

Requirements:

• Advanced degree in life sciences, biomedical engineering, or a related medical/scientific discipline.

• 4 to 5 years of experience

  in clinical evaluation, medical writing, or a related role in the medical device industry, with a focus on clinical evaluation documentation
• Proven experience in medical writing, with a strong focus on clinical evaluation documentation for medical devices.
• In-depth knowledge of EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, and relevant ISO standards (ISO 13485, ISO 14155).
• Excellent ability to critically appraise clinical data and present well-organized, scientifically sound reports.
• Strong technical and medical writing skills, with an ability to convey complex information clearly and concisely.
• Experience with regulatory submissions and addressing Notified Body/Competent Authority queries is a plus.