21 Cfr Jobs

Lead device and combination product regulatory strategy and submissions for AbbVie's Eyecare portfolio in a hybrid Senior Manager, Regulatory Affairs Device role based in Irvine, CA.

Lead IT for Phase 3 Development at ORIC, driving Veeva Vault implementations, CSV and inspection readiness across Clinical, Regulatory, Quality and Drug Safety.

Senior NQA Engineer needed to lead the site Nuclear Quality Management System, audits, root-cause analyses, and corrective actions for John Crane's Morton Grove facility.

Cresilon offers a paid 10-week onsite summer internship program where interns work on focused projects across R&D, Quality, Manufacturing, Data Analytics, Regulatory, and related functions to gain hands-on industry experience.

Lead cross-functional QMS improvement projects at Penumbra to ensure regulatory compliance and drive system-driven quality solutions.

Experienced RA/QA professional needed to support CAPA management, vendor qualification, documentation control, and audit readiness for a MedTech CRO on a remote, temporary contract.

Experienced medical device program leader needed to own strategic client portfolios, drive cross-functional delivery, and grow Eurofins’ footprint across testing and consulting services.

Experienced IT business analyst needed to lead strategic planning and solution delivery for Biologics Clinical Manufacturing systems at Gilead's Foster City site.

Eko is hiring a hybrid Product Quality Assurance Engineer to lead QMS activities, design control, and risk/validation efforts for FDA-regulated hardware+software medical devices.

Becton, Dickinson (BD) is hiring a Quality Engineer II to manage quality systems, investigations, and process controls for instrument manufacturing at the Sparks, MD facility.

Experienced quality/process engineer needed to lead validation, technical transfer, and continuous improvement efforts at a regulated manufacturing facility in Sanford, ME.

AbbVie is hiring a Systems Engineer to manage and maintain Design History Files for medical devices, ensuring traceability, compliance with FDA/ISO standards, and readiness for regulatory submissions and audits.

Intuitive is hiring a Supplier Manufacturing Engineer to qualify, develop, and drive continuous improvement at suppliers producing components for high-volume medical devices, with emphasis on MIM and injection molding.

Lead design verification strategy and execution for advanced drug-delivery and combination product systems within AbbVie's Device & Combination Product Development team.

Lead global deployment, training, and validation of enterprise quality and document management systems to ensure compliant, effective user adoption across Eurofins laboratories.

Experienced Quality Engineer needed to lead CQV and validation activities for Capricor's GMP facility in San Diego, ensuring regulatory compliance and driving continuous improvement.

Jade Biosciences is hiring an Associate Director, Compliance to lead GxP audit strategy and supplier compliance across its biologics development programs.

AbbVie is hiring a Staff Product Development Engineer to lead early-stage regenerative medicine device projects, delivering prototype design, verification, and risk-managed solutions in a regulated R&D setting.

Foresight Diagnostics is hiring an onsite QA Specialist in Boulder to maintain and advance QMS compliance (ISO 13485, 21 CFR 820, CAP/CLIA) and provide hands-on QA support to laboratory operations and process development.

Celerion is hiring an EDC Test Analyst to perform UAT and validate clinical databases and systems to ensure compliant, timely study execution across clinical trials.

Capricor Therapeutics is hiring a Quality Engineering Associate II to support GMP operations, validation, audit readiness, and continuous improvement at its San Diego biologics facility.

Intuitive is hiring a Quality Engineer 2 to support sustaining manufacturing, design verification, and quality improvement activities for da Vinci Multiport systems in Peachtree Corners, GA.

Lead and elevate Frida’s Quality Assurance function by building and executing an ISO 13485/FDA-aligned QMS, driving supplier quality, testing, audits, and CAPA across new product development and legacy ranges.