Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Empower global product registration by managing regulatory submissions, collaborating across teams, and ensuring compliance with market regulations. Lead initiatives that drive strategic growth while...

Lead the charge in ensuring compliance and efficiency in the IVD labeling conversion process while collaborating across departments to maintain project timelines and technical accuracy...

Drive regulatory excellence by shaping compliance strategies for medical robotics. Collaborate across teams to manage submissions, enhance processes, and mentor talent while navigating complex regulat...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

Optimize regulatory compliance processes to ensure product quality and adherence to global standards while coordinating submissions and managing cross-functional teams for effective risk management...

Drive regulatory excellence by overseeing compliance for product claims, labeling, and ingredient evaluations. Collaborate with teams to ensure timely submissions and strategic solutions for regulator...

Join a team that's shaping global regulatory strategies for innovative medical devices. Leverage your expertise in Software as a Medical Device (SaMD) to make impactful submissions and ensure complian...

Elevate your career as you ensure regulatory compliance in product development and manufacturing. Collaborate with project teams and guide submissions to domestic and international agencies while main...

Drive global regulatory strategy for medical imaging products, ensuring compliance across the software development lifecycle. Lead a dynamic team, engaging with cross-functional partners and regulator...

Shape your career by supporting regulatory compliance for clinical investigations and product distribution worldwide. Contribute to approvals and quality standards in a collaborative environment while...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Manage site-level regulatory operations for clinical trials, ensuring compliance with U.S. regulations. Collaborate with cross-functional teams and provide guidance for regulatory submissions, fosteri...

Seeking a detail-oriented Regulatory Affairs Specialist to manage medical device compliance, documentation, and audits, ensuring adherence to FDA and ISO standards while collaborating across teams for...

Drive regulatory strategy by guiding product development teams, ensuring compliance, and preparing documentation for global submissions. Monitor regulations and assess their impact, while fostering so...

Partner with us to ensure seamless FTZ operations and compliance for cell therapy logistics. You'll manage inventory integrity and align cross-functional teams to support critical patient material shi...

Drive regulatory compliance for cutting-edge surgical medical devices, enhancing product access globally. Collaborate cross-functionally and provide guidance on regulatory strategies, ensuring alignme...

Transform the future of diabetes care by guiding innovative medical devices through regulatory pathways, influencing product strategies, and ensuring compliance with global regulations while collabora...

Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...

Join a team that's dedicated to enhancing healthcare compliance. This role requires expertise in regulations and standards, managing projects, and fostering team growth while ensuring client facilitie...

Engage in regulatory affairs to support product development, IVDR implementation, and global registrations. You'll contribute to compliance processes and cross-functional collaboration to ensure audit...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Champion global regulatory strategies by leading diverse teams in navigating complex approval processes for medical devices. Drive compliance and ensure optimal product launch pathways while addressin...

Lead critical clinical strategies and ensure regulatory compliance while collaborating across teams to uphold data integrity and support product development initiatives in a dynamic environment...

Champion quality assurance by ensuring compliance with standards, managing documentation, and supporting supplier quality and audits for operational excellence in a regulated environment...

Transform Quality Systems by analyzing data and developing impactful executive presentations. Collaborate with global teams to support QMS processes, ensuring timely delivery of insights for managemen...