Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Explore a dynamic role requiring strong communication and analytical skills. Collaborate with clinical personnel and key opinion leaders while ensuring compliance with medical device regulations and c...

Lead the charge in ensuring compliance with global regulatory and quality standards for medical devices. Collaborate across teams to prepare essential documentation and support regulatory submissions...

Empower government sector success by identifying sales opportunities and leveraging legal tech expertise. Join a dynamic team to boost revenue through strategic outreach and relationship building whil...

Analyze and develop compliance documentation for medical devices, ensuring alignment with regulatory standards. Collaborate with cross-functional teams to support product lifecycle activities and main...

Join our team to lead Quality Assurance efforts, ensuring compliance with regulatory standards while supporting clinical and manufacturing operations. Drive quality initiatives and mentor a dedicated...

Transform the regulatory landscape by leading CMC strategies for biologic, cell, and gene therapy products. Drive compliance, manage submissions, and collaborate with cross-functional teams to ensure...

Optimize regulatory operations by ensuring compliance with evolving standards, managing audit readiness, and collaborating with cross-functional teams to maintain an effective quality system in a dyna...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Champion regulatory excellence by leading European strategies for innovative therapies. Drive successful submissions and interactions with health authorities, ensuring compliance and alignment across...

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

Drive regulatory business development by leading assessments, formulating strategies, and managing cross-functional teams to identify and mitigate risks in new opportunities, ensuring alignment with c...

Shape the future of clinical trials by leading site monitoring efforts, ensuring compliance, and fostering collaboration across teams. Drive quality and efficiency in trial execution while mentoring j...

Bring your expertise to drive supplier quality excellence, implementing quality plans, managing audits, and fostering improvements. Collaborate with engineering teams to enhance manufacturability and...

Optimize your sales expertise by driving revenue in state government sectors. Leverage your knowledge of procurement processes to build relationships and close deals, while collaborating with a top-ti...

Empower compliance excellence by leading the NSCLC field compliance program. Collaborate with cross-functional teams to identify risks, develop scalable solutions, and ensure adherence to regulations...

Join a dynamic team to drive preclinical evidence strategies and foster physician collaborations, enhancing innovative medical solutions that improve patient outcomes through strategic partnerships an...

Unlock project management excellence in Global Regulatory Affairs, driving timelines and compliance for drug submissions. Collaborate cross-functionally to ensure accurate documentation and effective...

Drive compliance excellence by managing global product projects across diverse markets. Collaborate with teams to ensure adherence to regulations for dietary supplements, foods, cosmetics, and medical...

Join a team that's dedicated to advancing space technology by developing and executing rigorous tests for avionics and electrical subsystems. Your expertise will ensure the reliability and performance...

Drive quality excellence by managing the MRB process and collaborating with cross-functional teams to resolve nonconformances, enhance production quality, and support hardware development in a dynamic...

Lead the charge in enhancing manufacturing quality by managing MRB processes, collaborating with cross-functional teams, and driving continuous improvement initiatives in an advanced aerospace environ...

Unlock potential by leading global site start-up strategies for complex clinical trials. Drive operational excellence, ensure compliance, and collaborate with cross-functional teams to accelerate stud...

Lead the global GMP/GDP audit organization, enhancing predictive compliance intelligence while mitigating risks through advanced analytics and effective audit strategies...

Advance clinical research by leading site monitoring and management efforts. Ensure compliance with regulatory standards while overseeing study protocols and data integrity. Collaborate with teams to...

Empower quality assurance excellence by leading GMP oversight for contract manufacturing and validation projects, ensuring compliance and collaboration across technical operations to support drug deve...