Regulatory Affairs Specialist US

1 week ago

Providence, United States Nordberg Medical Full time

Join to apply for the Regulatory Affairs Specialist US role at Nordberg Medical. The Regulatory Affairs Specialist US is responsible for preparing, reviewing, and maintaining regulatory submissions and documentation required for U.S. FDA approvals of high?risk and Class III implantable medical devices, including degradable and bioabsorbable implants. The role focuses on ensuring compliance with FDA regulations and supporting product lifecycle management from development to post?market activities. This position collaborates closely with global Regulatory Affairs colleagues, project managers, and cross?functional teams to drive efficient regulatory submissions and ensure continued compliance with U.S.?marketed devices. Key Responsibilities Prepare, review, and submit U.S. regulatory documentation, including Investigational Device Exemptions (IDE), Premarket Approval Applications (PMA), PMA Supplements, and 510(k) submissions. Evaluate and confirm completeness and accuracy of technical and clinical documentation to support U.S. registrations. Collaborate with global RA colleagues to align submission strategies and documentation. Support discussions with CROs, external consultants, and FDA representatives, leveraging internal and external networks, in collaboration with our Global Regulatory Strategy Director and Senior Regulatory Affairs Manager. Review labeling, IFUs, and promotional materials for compliance with U.S. regulations. Ensure regulatory compliance with FDA 21?CFR?807, 812, 814 and applicable guidance for PMA and 510(k) submissions. Participate in audits and FDA inspections as a Regulatory Affairs subject matter expert. Monitor changes in U.S. regulatory requirements and assess potential impact on products and documentation. Maintain accurate regulatory records and tracking systems in compliance with ISO?13485 and internal quality system procedures. Education Bachelors degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or related field. Experience About 35 years of regulatory affairs experience in the medical device industry, specifically working with degradable implants. Preferably in aesthetics injectables or orthopedics. Experience includes preparing, reviewing, and submitting regulatory documentation and responding to FDA inquiries; using regulatory information management systems or submission tools; working with CROs or external partners for regulatory submissions. Knowledge Strong understanding of U.S. FDA regulatory pathways, including either PMA or 510(k) processes. Familiarity with ISO?13485, ISO?14971, and FDA Quality System Regulations (QSR). Personality Adaptable and growth?minded: embraces learning opportunities and contributes to a positive, solutions?focused team culture. Detail?oriented and structured: ensures high accuracy and compliance in documentation and submissions. Collaborative communicator: works effectively with cross?functional teams and global colleagues. Independent and proactive: able to organize and manage work with minimal supervision, including in a remote setting. Other Information This is a full?time, remote?based position located in the United States. The role requires willingness to travel within the U.S. with occasional travel to Europe. Employment will be through Nordberg Medical (US) Inc. Please note that candidates must be legally authorized to work in the United States. We are unable to provide visa sponsorship for this position. #J-18808-Ljbffr

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