Project Manager R&D, Compliance

The Compliance Project Manager is a hands-on role responsible for executing and driving completion of critical quality and regulatory initiatives in medical devices/pharmaceuticals, including FDA 483 responses, CAPA remediation, and cross-functional process improvements. You will lead and coordinate internal projects across R&D, quality, regulatory, manufacturing, and product teams, ensuring timely, compliant, and traceable execution of commitments with strong regulatory alignment and clear documentation. Responsibilities include managing ongoing compliance activities, maintaining team engagement through transparent communication, driving process improvements, and leveraging tools like Smartsheet and Excel dashboards. Qualifications emphasize a Bachelor's degree in engineering or science, a minimum of 2 years in a medical device or pharmaceutical field, knowledge of design controls, risk assessments, and the 510(k) process, with preferences for PMP certification, regulatory agency experience, audits/inspections, and strong cross-functional collaboration skills.