Staff Clinical Evaluation Specialist (Remote)

We are seeking a Staff Clinical Evaluation Specialist to join our Instruments division. In this role you will collaborate closely with cross-functional teams including Regulatory Clinical Research Quality and Marketing to ensure the successful preparation of high-quality submission-ready clinical documents to enable global market availability. These include clinical evaluation reports post-market clinical follow-up documents summaries of safety and clinical performance and clinical study documentation. Candidates may be based Remote anywhere in the United States.

What you will do

• Lead the development authoring and revision of highquality clinical and regulatory documentation including regulatory submissions and presubs clinical evaluations postmarket 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 wellstructured regulatory documents.
• Design and execute compliant systematic literature reviews to capture assess and summarize published clinical evidence.
• Identify critically appraise and analyze clinical postmarket preclinical and marketing data to develop comprehensive scientific and clinical evidence packages including quantitative and qualitative analyses and riskmanagement crosschecks.
• 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 crossfunctionally 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 customerfacing 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 crossfunctional 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 evidencebased decisionmaking in the best interest of patients and customers.

What you need

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

Preferred

• Masters degree in a health or sciencerelated 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 crossfunctional 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 crossfunctionally with internal partners (Regulatory R&D Marketing) and external stakeholders (physicians CROs thirdparty partners).

United States of America Pay Ranges:

• USN: $95700 - $159500 USD Annual
• US5: $100500 - $167500 USD Annual
• US10: $105300 - $175500 USD Annual
• US15: $110100 - $183400 USD Annual
• US20: $114800 - $191400 USD Annual
• US30: $124400 - $207400 USD Annual