We are seeking a Staff Clinical Evaluation Specialist

What you will do

• Lead the development, authoring, and revision of high‑quality clinical and regulatory documentation, including regulatory submissions and pre‑subs, clinical evaluations, post‑market surveillance and PMCF reports, SSCPs, annual reports, and clinical studies supporting device safety and performance.
• Strong scientific writing skills with the ability to synthesize complex clinical data into clear, compliant, and well‑structured regulatory documents.
• Design and execute compliant systematic literature reviews to capture, assess, and summarize published clinical evidence.
• Identify, critically appraise, and analyze clinical, post‑market, preclinical, and marketing data to develop comprehensive scientific and clinical evidence packages, including quantitative and qualitative analyses and risk‑management cross‑checks.
• Synthesize complex scientific and technical information into clear, concise, and scientifically accurate clinical documents, maintaining documentation throughout the full product lifecycle.
• Serve as a clinical evidence subject matter expert, partnering cross‑functionally with Regulatory Affairs, Clinical Research, Marketing, and Reimbursement & Market Access to support evidence communication and business alignment.
• Translate clinical and scientific data into accessible formats for diverse audiences, including regulators, healthcare professionals, and customers; support development of manuscripts, conference posters and presentations, white papers, and customer‑facing materials.
• Communicate and negotiate with global regulatory bodies on clinical evidence requirements, leading issue resolution to ensure successful regulatory submission acceptance.
• Independently resolve content questions and feedback from internal and external reviewers; coordinate cross‑functional review cycles and ensure timely document approvals.
• Support new product development by providing clinical input to design teams, intended use and indications for use statements, risk files, and product claims.
• Support product sustainment initiatives to maintain market availability and enable new or expanded claims based on evolving clinical evidence.
• Review marketing collateral to ensure accuracy, consistency, and compliance of clinical claims.
• Foster open scientific dialogue and appropriately challenge conclusions to ensure evidence‑based decision‑making in the best interest of patients and customers.

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What you need

• Bachelor of Science degree in a health‑ or science‑related discipline required.
• Minimum of 4+ years of industry experience in clinical, quality, or regulatory affairs (e.g., risk management, design quality, post‑market safety).
• At least 3 years of direct experience authoring clinical evaluations for medical devices, including preparation of submission‑ready clinical evidence documentation.
• Demonstrated experience analyzing clinical, post‑market, and preclinical data in accordance with global regulatory requirements (e.g., FDA, EU MDR).

Preferred​

• Master’s degree in a health‑ or science‑related field preferred; PhD strongly preferred.
• Strong ability to interpret and apply regulations, technical standards, guidance documents, and complex clinical and technical data to support regulatory and market access strategies.
• Demonstrated ability to understand and clearly communicate new medical topics, including disease states, treatment rationales, surgical techniques, and clinical outcomes.
• Proven success managing complex, cross‑functional projects in a regulated environment.
• Strong communication, project management, influencing, and negotiation skills; effective at communicating across all organizational levels and with external stakeholders.
• Demonstrated effectiveness working cross‑functionally with internal partners (Regulatory, R&D, Marketing) and external stakeholders (physicians, CROs, third‑party partners).

• Total Base Pay Range $95,700.00 - $159,500.00 USD Annual salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Posted: April 17, 2026

Posted Date: 04/17/2026
This role will be posted for a minimum of 3 days.