IVDR Product Reviewer

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an IVDR Product Reviewer based in the United States.** Contribute to the safety, quality, and regulatory compliance of in vitro diagnostic (IVD) medical devices by evaluating technical documentation against applicable European regulatory requirements. In this role, you will conduct independent and collaborative assessments of product design dossiers and technical files to determine whether devices meet the requirements for CE marking. You will analyze scientific and technical evidence, assess conformity with relevant standards, and prepare comprehensive reports that support informed certification decisions. Working alongside clinical experts, technical specialists, performance evaluators, and certification project managers, you will help ensure consistent, rigorous, and timely assessments. You will also monitor evolving regulations, share technical knowledge, and contribute to professional training and industry discussions. This opportunity is ideal for an experienced healthcare or medical device professional with strong analytical skills, scientific expertise, and a commitment to impartial evaluation. Your work will help strengthen regulatory confidence and support the availability of safe, effective, and reliable diagnostic technologies. ### Accountabilities - Conduct CE type examinations and design dossier or product assessments for in vitro diagnostic medical devices and other medical devices within your area of expertise, applying the relevant European regulatory frameworks and requirements. - Independently review or collaborate with other evaluators to assess technical documentation, design dossiers, and supporting evidence for conformity with applicable regulations, standards, and technical requirements. - Evaluate the evidence submitted by manufacturers to determine whether devices meet applicable safety, performance, quality, and intended-use requirements. - Prepare comprehensive, accurate, and evidence-based assessment reports that clearly document findings, identify deficiencies, and support or reject applications for CE marking based on the available evidence. - Collaborate with product reviewers, clinical experts, performance evaluators, process specialists, technical experts, and certification project managers to coordinate assessments and meet established deadlines. - Consolidate assessment findings and communicate technical conclusions clearly to ensure consistency, accuracy, and quality across review activities. - Monitor applicable regulatory developments, standards, and technical guidance within your areas of expertise, communicating relevant changes and emerging requirements to colleagues. - Participate in technical and regulatory workshops, standardization activities, industry events, and speaking engagements as appropriate. - Contribute to knowledge sharing and professional development by preparing or delivering training sessions, technical presentations, and educational activities. - Maintain impartiality, confidentiality, and professional integrity throughout all evaluation activities, ensuring that decisions are based on objective evidence and applicable requirements. - Organize and prioritize multiple assessments, manage competing deadlines, and maintain reliable records and documentation throughout the review process. - Perform additional duties and responsibilities as assigned to support assessment quality, regulatory compliance, and departmental objectives. ## Requirements - **Education:** A university or technical college degree, or an equivalent qualification, in a relevant discipline such as medicine, pharmacy, engineering, or another scientific field. - **Professional Experience:** At least four years of professional experience in healthcare products or related activities, including manufacturing, auditing, research, or comparable work. - **Relevant Technical Experience:** At least two years of experience in the design, manufacture, testing, or use of the medical device or technology being assessed, or in scientific activities relevant to the assessment. - **Regulatory Knowledge:** Understanding of medical device and in vitro diagnostic regulatory requirements, particularly the European regulatory framework for CE marking and applicable conformity assessment procedures. - **Technical Assessment Skills:** Ability to review complex technical documentation, interpret scientific evidence, evaluate product conformity, identify gaps, and develop well-supported assessment conclusions. - **Scientific and Analytical Expertise:** Strong critical reasoning skills and the ability to apply scientific knowledge, technical standards, and regulatory requirements to product evaluations. - **Technical Writing:** Excellent written communication skills, with the ability to prepare clear, structured, detailed, and evidence-based technical reports and assessment records. - **Verbal Communication and Presentation:** Ability to explain technical findings clearly, present complex information to diverse audiences, and participate effectively in technical discussions and training sessions. - **Organization and Time Management:** Strong organizational skills, attention to detail, and the ability to manage competing priorities while consistently meeting review deadlines. - **Collaboration:** Ability to work independently while collaborating effectively with multidisciplinary teams, technical specialists, and certification stakeholders. - **Professional Integrity:** Demonstrated commitment to confidentiality, impartiality, objectivity, reliability, and accountability when reviewing product documentation and making technical judgments. - **Regulatory Monitoring:** Ability to stay informed about evolving regulatory requirements, technical standards, and industry practices relevant to medical devices and IVDs. - **Adaptability:** Willingness to work across different device types and technical subject areas according to your expertise and assigned responsibilities. - **Work Environment Readiness:** Ability to perform duties remotely, from an office, or at client sites when required. - **Travel Availability:** Willingness to undertake occasional business travel as necessary. ## Benefits - **Full-time professional opportunity:** A full-time, exempt position with an expected workload of at least 40 hours per week. - **Remote work arrangement:** Flexibility to work remotely from within the United States, with potential activities at client sites or office locations. - **Scientific and technical impact:** Contribute to the evaluation of medical technologies that support patient safety, diagnostic reliability, and regulatory compliance. - **Specialized professional development:** Opportunities to deepen expertise in IVD technologies, technical documentation assessment, CE marking, and European regulatory requirements. - **Cross-functional collaboration:** Work with clinical experts, technical specialists, performance evaluators, and certification professionals. - **Knowledge-sharing opportunities:** Participate in technical workshops, regulatory discussions, standardization activities, and training sessions. - **Independent technical responsibility:** Take ownership of product assessments and develop expertise in evidence-based regulatory decision-making. - **Varied technical scope:** Evaluate a range of medical devices and IVD products according to your professional background and area of specialization. - **Compensation details:** The original job posting does not specify a salary range. - **Healthcare and additional benefits:** Specific medical insurance, retirement plans, paid time off, and other employee benefits were not detailed in the source description and should be confirmed during the recruitment process.