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...

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...

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...

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...

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...

Advance global regulatory strategy and submissions for rare disease medicines across major markets, partnering with stakeholders to ensure compliance and successful engagement with health authorities...

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...

Shape the future of regulatory compliance by leading lifecycle management projects, coordinating approvals, and developing strategies for new medical devices, while fostering relationships with teams...

Lead the charge in regulatory strategy for ophthalmologic products, ensuring compliance with global standards. Manage submissions, coordinate projects, and oversee promotional materials. Join a dedica...

Join a team dedicated to ensuring drug quality compliance by performing data integrity audits, assessing adherence to FDA standards, and providing actionable recommendations to enhance regulatory deci...

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...

Join a team that's passionate about advancing regulatory projects in the pharmaceutical industry. Drive compliance and ensure timely submissions while collaborating across functions, developing strate...

Champion the development of CMC regulatory submissions and strategies, ensuring compliance with global standards. Collaborate with cross-functional teams while maintaining accuracy in documentation to...