Clinical Evaluation Specialist

Work Flexibility: Hybrid

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

• Delivers results.  A driven player who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks

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: University degree (PhD, Master’s 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 5 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 preferred  

• Experience with orthopedic or trauma devices preferred 

• 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. 

Travel Percentage: 10%