Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert)

Key Responsibilities

• Lead the development and maintenance of Clinical Evaluation Reports (CERs) in accordance with EU MDR Annex XIV and applicable MEDDEV guidance.
• Develop comprehensive clinical evidence strategies for Class III cardiac ablation catheters and generators.
• Interpret and apply EU MDR clinical requirements to support product development, regulatory submissions, and lifecycle management activities.
• Provide strategic guidance regarding clinical data requirements, PMS, PMCF and PSUR activities, and benefit-risk determinations.
• Support interactions with Notified Bodies and Competent Authorities regarding clinical evidence and clinical evaluation requirements.
• Monitor evolving European regulatory expectations, MDCG guidance documents, harmonized standards, and industry best practices.

Key Duties

• Design and oversee clinical investigations, registries, observational studies, and post-market clinical follow-up (PMCF) programs.
• Conduct systematic literature reviews and clinical data analyses to support regulatory submissions and clinical evaluations.
• Evaluate scientific literature, adverse event data, complaint trends, and post-market surveillance information to establish device safety and performance.
• Lead clinical evidence gap assessments and recommend appropriate mitigation strategies.
• Develop Clinical Evaluation Plans (CEPs), PMS, PMCF Plans, PMCF Evaluation Reports, PSURs and Summary of Safety and Clinical Performance (SSCP) documentation.

Data Analysis & Scientific Leadership

• Perform advanced analyses of clinical and post-market data to support safety, efficacy, and performance claims.
• Provide statistical interpretation and scientific rationale for clinical conclusions and regulatory positions.
• Critically evaluate competitor and predicate device clinical evidence to support strategic regulatory initiatives.
• Present clinical findings and recommendations to executive leadership, regulatory bodies, and cross-functional teams.

Cross-Functional Collaboration

• Partner with Regulatory Affairs to support CE Mark submissions, significant change assessments, and product renewals.
• Collaborate with Quality teams to ensure alignment between clinical evidence and risk management documentation.
• Support Engineering teams by providing clinical input during product development and design validation activities.