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 doThe Clinical Evaluation Specialistacts as the lead technical expert in driving this highly complex and demanding process. He/she applies scientific, regulatory and project management skills toestablish the evaluationstrategy andtocompile the body of Clinical Evidence, allowing, in collaboration with the Medical Expert, toreach a legally binding scientific conclusion on the safety and performance ofdevicesin patients, throughout the product lifecycle.The Clinical Evaluation Specialist bears the operational and regulatory responsibility ofindividual clinical evaluation reportsand 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).
- Designingcompliant and sustainable literature search strategies, and performingcomplex literature queries toretrievepublished clinical data,
- Identifying, appraising,and analyzingall 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.
- Analyzingthe 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 regulatoryrequirements,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 anddevelopingClinicalEvaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.
- SupportingMarketing 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, helpingto 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, Masters or equivalent) in a field related to the life sciences or a relevant medical engineeringfield (biology, physiology, biomaterials, biomedical engineering or similar).
- Experience: 3to5years of experience in Scientific or Medical Writing, and/orrelevantacademicor clinicalresearch experience (PhD, Post-doc)
- Experience in clinical or regulatory affairs preferred
- Experience withorthopedic or trauma devices preferred
- Proactive, independent, team player with a strong service mentality.
- You arecharacterized 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%
