Senior Clinical Evaluation Specialist - Cork, Carrigtwohill IDA Business & Technology Park Innovation Centre

Work Flexibility: Hybrid

The Senior Clinical Evaluation Specialist is responsible for setting the clinical evidence strategy for new and existing medical devices. This role is responsible for the planning, creation, and update of Clinical Evaluation Plans, Clinical Benefit-Risk Assessments, Clinical Evaluation Reports and associated documentation (PMCF plans, PMCF reports, SSCP’s, or evidence dossiers) in order to bring and/or maintain medical devices on the global market.  This role is responsible for assessing compliance with internal and external safety and performance requirements for medical devices, by reviewing, analyzing and forming conclusions on clinical evidence. It leads complex projects, participates in dialog with regulatory agencies, contributes to determining long-term overarching departmental strategies, and provides inputs on regulatory and clinical trends. The Senior Clinical Evaluation Specialist role bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them in audit situations. 

The Senior Clinical Evaluation Specialist is a proactive and independent team player with a strong service mentality. This position is characterized by analytical and transdisciplinary reasoning, with excellent attention to detail. This position values an international working environment, working across sites and indications.

Tasks include:

• Develop and implement a comprehensive clinical evidence strategy throughout the new product development cycle, considering regulatory requirements, intended use, and risk classification. Responsible for global clinical development plan for all key regions including proposed Market Access and Sustaining activites.  
• Collaborate with regulatory affairs on Clinical Evidence requirements to ensure the successful acceptance of regulatory submissions.
• Foster alignment with adjacent complex processes such as marketing strategy and claims, regulatory strategy, clinical research strategy, or reibursement strategy (where applicable).
• Oversees clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).
• Support the needs of other functions (R&D, Marketing, Clinical Research, Reimbursement) regarding communication of clinical data in the form of peer-reviewed publications, white papers, 1-pagers, clinical summaries, posters, and slide decks/presentations.
• Design compliant and sustainable literature search strategies and performs systematic reviews to capture and summarize published clinical data.
• Analyze current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
• Acts as the dedicated Clinical Evaluation Project Manager, driving the establishment of a coherent Clinical Evidence strategy
• throughout the new product development cycle and fosters alignment with adjacent processes as applicable (e.g., marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy).
• Identifies, appraises, and analyzes relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks.
• Forms a conclusion on the overall benefit-risk profile of the subject device, in collaboration with a Medical Expert and other stakeholders, based on up-to-date US, European, and other country’s regulatory requirements.
• Identifies unanswered questions and residual risks in the Clinical Evidence and designs Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.
• Represent expertise during internal and external quality system audits.
• Support design of clinical evidence gathering activities (such as clinical trials, PMCF studies, registries, surveys) to support clinical evidence needs in collaboration with the clinical research team executing the studies.
• Support creation of study synopses and clinical investigation plans to support market clearance and/or required post-market surveillance.
• Review promotional and/or marketing material to support product launches, market access, etc.

Minimum of master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) is required

Minimum of 6 years industry experience in clinical, quality or regulatory affairs (Risk Management, Design quality, Post Market Safety etc.)

• 2 to 5 years of experience in Scientific or Medical Writing, and/or relevant academic or clinical research experience (PhD, Post-doc)
• Experience in clinical, regulatory, or quality affairs preferred.
• Experience with medical devices preferred.

• Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
• Good understanding of clinical regulations for major regions.                                                                                                
• Successful track record in managing complex projects.
• Documented expertise on one or more disciplines linked to clinical evaluation (e.g. regulatory requirements, data analysis, critical appraisal etc)
• Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence.
• Ability to train and mentor junior team members
• Demonstrated ability to drive innovation and set direction within the group in internal procedures and best practices.
• Ability to effectively present information to other employees, management, and regulatory agencies.
• Excellent MS Office Skills and IT proficiency.

Travel Percentage: 20%