The Clinical Evaluation Specialist in the Medical Affairs team plays the lead role in the planning, creation, update of Clinical Evaluation Reports Clinical Benefit-Risk Assessments, Clinical Evaluation Reports and associated documentation (PMCF plans, PMCF reports, SSCP’s)

What you will do:

The Clinical Evaluation Specialist acts as the lead technical expert in driving this highly complex and demanding process. He/she applies scientific, regulatory and project management skills to establish the evaluation strategy and to compile the body of Clinical Evidence, allowing, in collaboration with the Medical Expert, to reach a legally binding scientific conclusion on the safety and performance of devices in patients, throughout the product lifecycle.

The Clinical Evaluation Specialist bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them in audit situations.

Tasks include

• Driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy).Designing compliant and sustainable literature search strategies, and performing complex literature queries to retrieve published clinical data,

• Identifying, appraising and analyzing all relevant (clinical, PMS, marketing and testing data) from multiple sources and formats and create a comprehensive scientific review, including in depth statistical analyses, risk management cross-check and descriptive analyses, following complex and rigorous methodologies. 

• Analyzing the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.Based on a detailed and up-to-date understanding of US, European and Australian regulatory requirements and expectations, elaborate and defend, with the Medical Expert, a conclusion on the overall risk-benefit statement.

• Identify unanswered questions and residual risks in the Clinical Evidence, and design Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions. 

• Defining and developing Clinical Evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.

• Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence.

• With the Medical Experts, helping to define, plan, and initiate clinical studies and in vitro tests together with all stakeholders from Clinical Research, R&D, Biomechanics and Regulatory.    

What You need:

Education

• Bachelor’s Degree or equivalent in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar).

Experience

• 3 to 6 years of experience in Scientific or Medical Writing, and/or relevant academic or clinical research experience (PhD, Post-doc)

• Experience in clinical or regulatory affairs preferredExperience with orthopedic or trauma devices preferred

Competences

• Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.

• Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence.Ability to effectively present information to other employees, management, and regulatory agencies.

• Good MS Office skills and general IT proficiencyAbility to travel domestically and internationally up to 20%.

• Proactive, independent, team player with a strong service mentality. You are characterized by analytical and transdisciplinary reasoning, with a good attention to detail. You value an international working environment, working across sites and indications.