Fda Jobs

Lead the engineering transformation at Alcon's Houston manufacturing site by delivering automation, Industry 4.0, CI-driven savings, and an energy transition while building a high-performing engineering organization in a regulated environment.

Lead mechanical design and development of next-generation minimally invasive surgical robots at Intuitive, applying deep mechanical engineering expertise to prototype and production systems.

Lead packaging engineering at Elanco's Clinton manufacturing site as the technical owner for packaging materials, equipment, compliance, and continuous improvement.

Lead commercial strategy and full-cycle sales for an FDA-cleared healthcare AI company as the VP of Revenue, driving rapid growth across U.S. and international markets with a path to CRO.

Medtronic is hiring a Senior Engineering Manager to lead quality engineering for CST Platforms & Solutions, guiding product and software development from design through market release in Lafayette, Colorado.

Medtronic is hiring a Quality Engineer II to support on-site manufacturing quality for Class II surgical devices in Boulder, focusing on investigations, corrective actions, validation, and process improvements.

Technical regulatory leader sought to author and drive FDA regulatory strategy and submissions for AI/ML-enabled SaMD at a fast‑moving digital health company.

AssistRx is hiring a hands‑on Senior QA Manager to drive quality oversight for patient support programs, ensuring compliance with sponsor standards, pharmacovigilance requirements, and continuous improvement initiatives.

AbbVie is hiring a Senior Quality Engineer to lead manufacturing QA activities at its Tempe site, ensuring product quality, regulatory compliance, and continuous process improvement.

Join Pattern as an Ecommerce Compliance Specialist to audit listings, resolve marketplace compliance issues (Amazon, Walmart, TikTok Shop), and protect partner revenue through proactive remediation and regulatory research.

Medtronic is hiring an experienced Engineering Manager to lead device development teams at its Mounds View facility, combining technical depth and strategic leadership to accelerate compliant product delivery.

Medtronic is hiring a Post Market Quality Engineer II to analyze post-market data, conduct health risk assessments, and support CAPA and regulatory compliance efforts to improve device safety and performance.

Experienced MDs with strong clinical research leadership and an active Mississippi license are invited to lead site operations and medical oversight as a Principal Investigator on a 1099 contract.

Experienced pharmacovigilance scientist needed to lead safety strategy, case review, signal detection, and aggregate reporting for early clinical development programs at a clinical-stage biopharma.

AbbVie is hiring a Senior Manager to lead US advertising and promotion regulatory activities for immunology products, ensuring compliance and strategic alignment across cross-functional teams.

AbbVie seeks an Associate Data Analyst in Tempe to manage vigilance reporting, regulatory submissions, and stakeholder communications for pharmaceutical and device complaints.

Experienced quality professional needed to lead CAPA investigations and improvements at AbbVie's Tempe manufacturing site to ensure compliant drug product and packaging operations.

Lead strategic DTC patient marketing and omnichannel campaign delivery for pharma clients as the Senior Account Director, Patient at a remote-first agency.

Responsible for coordinating and executing transportation of GMP and non-GMP materials across AbbVie's global network to ensure compliant, timely, and efficient supply chain operations.

QRC Group is hiring a Sr Associate Tech Engineering to troubleshoot mechanical equipment, Rockwell PLCs and Cognex vision systems while supporting cGMP-compliant operations at client facilities in Juncos, Puerto Rico.

Lead and grow a cross-disciplinary product engineering team at a market-leading medical robotics company to deliver robust endoscope architectures and drive product development through verification, validation, and transfer to manufacturing.

Hippocratic AI is seeking a results-driven VP of MedTech & Devices in Palo Alto to lead commercial strategy, solution design, and revenue execution for medical device customers.

CRB is hiring an Industrial Engineer II to develop and validate simulation models that optimize workflows, equipment utilization, and facility layouts for regulated manufacturing facilities.

Experienced regulatory professional needed to drive U.S. regulatory strategy and submissions for complex robotic, electromechanical, and SaMD products at a leading surgical robotics company.

ARK Diagnostics is seeking an experienced Senior Clinical Affairs Specialist to lead clinical validation studies, specimen acquisition, and regulatory documentation for IVD assays at the Fremont, CA facility.

Lead quality strategy and design-control activities for next-generation robotic-assisted surgical products at a market-leading medical device company.

Lead systems-level architecture and program execution for advanced oximetry and wearable monitoring products at Medtronic’s Lafayette, CO site, spanning custom silicon, embedded firmware, signal processing, and device software.

Crinetics is hiring an experienced Associate Director, Quality Assurance GCP to lead GCP QA activities, drive inspection readiness, and embed risk-based quality oversight across its clinical development programs.

PCI Pharma Services seeks a QA Specialist II - Compliance in Bedford, NH to lead internal and client audits, manage corrective actions, and support regulatory inspections to ensure adherence to cGMP/GCP quality standards.

Experienced V&V engineer needed to lead verification and validation efforts for software-enabled medical devices, ensuring regulatory compliance and product quality across cross-functional teams.

ARK Diagnostics is hiring a Regulatory Affairs Specialist II to manage international device registrations, prepare regulatory submissions (including 510(k), De Novo, and IVDR technical documentation), and support lifecycle compliance for IVD and medical device products.

Medtronic is hiring a Senior Engineering Program Manager (Quality Core Team Member) to lead quality strategy and design assurance for cardiac surgery product development in Brooklyn Park, MN.

Medtronic is seeking a Product Engineer II to own design support and continuous improvement for wound management devices in high-volume production, focusing on yield, root cause analysis, supplier changes, and device quality.

Blueprint is hiring a Director of Product Development to lead formulation, validation, and commercialization of functional nutrition products with full accountability for quality, timelines, and outcomes.

Provide expert Tier 1 technical phone support and remote diagnostics for Intuitive's robotic surgical systems while documenting and driving resolutions through CRM and knowledge-base contributions.

Nextern is looking for a Senior Systems Engineer to lead system architecture, risk management, and verification/validation for electro-mechanical medical device projects.

Experienced regulatory/quality professional needed to maintain QMS activities, drive CAPA and change control, and support audit and regulatory documentation for a growing medical device company in New York State.

Senior Medical Editor needed to lead medical editorial quality and compliance for pharmaceutical marketing materials within a fast-paced life sciences agency.

Remote Senior Software Engineer needed to develop and maintain medical informatics applications that meet FDA device software requirements and support clinical users.

Remote Senior/Lead Software Engineer needed to develop and maintain FDA-compliant medical informatics applications using .NET/C# and web technologies.

Work remotely as a Senior Software Engineer building medical informatics applications that support clinicians and patients across diverse care settings.

Senior Software Engineer needed to design, build, test, and maintain medical informatics applications with an emphasis on patient safety and FDA-regulated software.

Senior Software Engineer (remote) to design, develop, test and maintain medical informatics software using .NET/C# and web technologies while ensuring FDA regulatory and patient-safety compliance.

Work remotely as a Senior Software Engineer building medical informatics applications that directly support clinicians and patients across diverse care settings.

Work remotely as a Senior Software Engineer building FDA-regulated medical informatics applications using .NET and C# to support clinicians and patients.

Senior Software Engineer needed to design, build, and maintain medical informatics applications using .NET/C# in a remote role that emphasizes patient-safety, regulatory compliance, and cross-functional collaboration.

Sobi is hiring a Technical Lead to drive analytical method development, lifecycle management and external lab oversight supporting small‑molecule drug substance and product from development to commercialization.

Senior regulatory leader needed to lead Sobi’s Global Advertising & Promotion team, drive regulatory strategy and FDA interactions, and own the global review process for promotional and corporate materials.

Greenberg-Larraby, Inc. is hiring a Clinical Engineer (Patient Safety) to lead medical device risk assessments, develop safety protocols, and collaborate with clinical teams on government-contracted projects.

Veterans Engineering is hiring a Biomedical Technician/Equipment Support Specialist II to maintain, calibrate, and repair medical devices for government healthcare clients while ensuring regulatory compliance and training clinical staff.