Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Shape the future of health technology by driving regulatory strategies for innovative lab testing, imaging, and AI products. Collaborate with cross-functional teams to ensure compliance and accelerate...

Join a team that's advancing global health by supporting critical clinical trial submissions. In this role, you'll lead regulatory strategies, ensure compliance, and collaborate with diverse teams to...

Drive regulatory intelligence initiatives to ensure compliance and support clinical research. Collaborate with experts to assess regulatory changes, track global guidelines, and enhance impact assessm...

Champion regulatory strategies to accelerate product approvals and compliance. Lead a dynamic team in supporting innovative medical devices, ensuring alignment with global regulations while fostering...

Shape the future of regulatory compliance by leading global submissions and strategies. Collaborate with cross-functional teams to ensure adherence to regulations while driving process improvements an...

Lead the charge in regulatory compliance by managing global submissions, advising on strategies, and ensuring adherence to standards. Collaborate with cross-functional teams to enhance efficiency and...

Drive regulatory data governance and process excellence across multiple product portfolios. Collaborate with cross-functional teams to enhance data quality, ensure compliance, and support digital tran...

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...

Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...

Join a dynamic team to enhance global regulatory compliance and market access for life-saving medical products. Collaborate with cross-functional teams to drive process improvements and navigate compl...

Champion regulatory excellence by leading submissions and compliance efforts. Collaborate with cross-functional teams to ensure alignment with FDA and international standards while driving projects to...

Transform regulatory strategies by providing CMC expertise to support product development and compliance in a dynamic pharmaceutical environment, ensuring quality and adherence to global standards thr...

Champion regulatory excellence by guiding product development teams, ensuring compliance with global standards, and fostering strong stakeholder relationships to drive business success...

Lead regulatory activities for global medical device registrations and submissions. Collaborate with cross-functional teams to ensure compliance with FDA and international regulations, managing docume...

Join a team that's dedicated to ensuring regulatory compliance for medical devices. In this role, you'll manage domestic and international filings, collaborate with regulatory teams, and support produ...

Innovate regulatory operations by managing submission preparation and execution, ensuring compliance with FDA and ICH standards. Collaborate cross-functionally to support complex filings and maintain...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

Champion global labeling strategy for innovative therapies, leading complex initiatives from development to post-approval. Collaborate with cross-functional teams to ensure compliance and high-quality...

Empower regulatory excellence by guiding cross-functional teams in compliance and strategy. Leverage deep FDA knowledge to influence promotional materials and ensure adherence to evolving regulations...

Transform life science R&D operations by leading initiatives that enhance efficiency and effectiveness across research, clinical, regulatory, and quality domains. Drive change through strategic projec...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...

Transform regulatory operations by leading teams to ensure compliance and quality in medical device submissions. Oversee projects, manage documentation systems, and drive continuous improvement to mee...