Director of Clinical Evaluation and Excellence

Advantage Technical
$148.00-$148.00
United States, Massachusetts, Acton
Dec 03, 2025
Ready to shape the future of clinical excellence in the medical device industry? Join a globally recognized innovator known for advancing patient health through evidence-driven research, rigorous quality systems, and world-class regulatory standards. If you thrive at the intersection of strategy, compliance, and clinical leadership-apply now. About the Role The Director of Clinical Evaluation & Excellence provides strategic oversight of global clinical research activities, ensuring compliance with evolving regulatory standards. This role leads global submissions, oversees safety reporting, and drives development of key clinical documents, including CERs and PMCF reports. You will also guide internal audits, support quality management system maintenance, and serve as a clinical subject matter expert across the organization. Key Responsibilities Lead global clinical development strategies aligned with organizational and regulatory goals. Oversee design, execution, and reporting of feasibility, pivotal, and post-market clinical studies. Ensure compliance with FDA, EU MDR, ISO 14155, and other global regulations. Represent Clinical Affairs in regulatory interactions and cross-functional forums. Prepare submissions for regulatory authorities and IRB/EC review; lead response strategies. Conduct gap analyses and update procedures based on regulatory changes. Oversee safety reporting, adverse event documentation, and device deficiency management. Lead internal audits, CAPAs, and inspection readiness efforts. Direct creation of CERs, CEPs, PMCF plans/reports, and clinical study reports. Manage and mentor a multidisciplinary team spanning regulatory, safety, quality, and writing functions. Promote a culture of compliance, collaboration, and continuous improvement. Qualifications Bachelor's degree in Life Sciences (advanced degree preferred). 10+ years in clinical research, regulatory affairs, or quality within medical devices. Strong leadership in global regulatory strategy and clinical documentation. Deep understanding of FDA, EU MDR, ISO 13485, ISO 14155, and GCP. Exceptional communication, organizational, and project management skills. RAC certification preferred. Apply today to lead a high-impact clinical function shaping global regulatory and research excellence. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.