Senior Regulatory Affairs Specialist Jobs in San Jose, CA

Lead global regulatory projects and ensure compliance in dynamic markets. Drive strategies for product approvals while mentoring teams and enhancing processes. Collaborate cross-functionally to naviga...

Transform regulatory strategies to ensure compliance and facilitate product availability for innovative medical devices in domestic and international markets. Collaborate with teams to navigate comple...

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...

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...

Champion regulatory excellence by leading diverse teams to ensure successful compliance and submission strategies for projects in the biotechnology and pharmaceutical sectors, while enhancing interact...

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...

Accelerate product success by leading regulatory initiatives from development to commercialization, ensuring compliance with FDA and international standards, while mentoring teams and making strategic...

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...

Champion the global regulatory strategy for complex CGT products, driving approval pathways and guiding cross-functional teams. Leverage your expertise in oncology and cell therapy to influence stakeh...

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...

Join a dynamic team as a Regulatory Affairs Specialist III, ensuring compliance with global regulations. Contribute strategically to product development and lifecycle management while collaborating ac...

Lead the charge in regulatory submissions for EU and ex-U.S. markets, managing CTA preparation and execution, while collaborating across teams to ensure compliance and timely approvals in a fast-paced...

Join a team dedicated to transformative regulatory compliance, focusing on EU and ex-U.S. clinical trial applications. Lead critical submission strategies and foster collaboration across functions to...

Unlock potential by driving continuous improvement of our global GxP Document Management Program. Oversee document control processes, ensuring compliance with industry standards while collaborating ac...

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 driving regulatory excellence in biotech, overseeing global submissions and health authority interactions. Collaborate cross-functionally to mitigate risks and ensure compliance thr...

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...

Unlock global regulatory strategies to drive the successful registration of IVD devices, ensuring compliance with international standards and guidelines. Collaborate across teams to support innovative...

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...

Drive the enhancement of GxP training programs in Quality Systems, ensuring compliance with regulatory standards. Collaborate across functions to assess training needs, design effective curricula, and...