Regulatory Affairs Specialist Jobs in Fremont, CA

Drive clinical excellence and customer satisfaction as you support healthcare professionals with educational insights and technical applications for innovative medical products, enhancing patient care...

Manage comprehensive risk-based quality audits across multiple sites, ensuring compliance with GCP standards. Collaborate globally with cross-functional teams to enhance clinical study integrity and c...

Drive global healthcare compliance operations by shaping strategies and optimizing processes. Collaborate with cross-functional teams to ensure compliance with laws and regulations while fostering eff...

Shape the future of reimbursement project assessments by leading technical reviews, guiding analysts, and establishing impactful frameworks, standards, and processes. Collaborate cross-functionally to...

Engineer impactful sterile and non-sterile packaging systems for medical devices. Collaborate across teams to enhance product commercialization and optimize packaging processes while ensuring regulato...

Transform customer experiences by validating instrumentation and providing expert training. Collaborate with cross-functional teams while traveling extensively to ensure operational excellence and hig...

Champion the execution of innovative marketing campaigns while collaborating with creative teams to drive digital recruitment initiatives and support sales efforts, ensuring optimal performance and st...

Transform your career with a Senior Product Safety Engineer role. Utilize your expertise in standards such as IEC 62368-1 and IEC 61010-1, support diverse projects, engage with clients, and guide juni...

Elevate our global labeling strategy by leading end-to-end processes, driving compliance, and optimizing product positioning through precise, defensible labeling language while collaborating across te...

Lead the charge in shaping innovative global regulatory strategies for complex molecules, ensuring efficient clinical pathways and successful health authority interactions throughout product lifecycle...

Drive regulatory excellence by providing expertise and executing compliant business processes. Influence cross-functional teams to navigate regulations and ensure timely submissions while supporting i...

Unlock your potential as a key leader in GxP auditing, driving compliance and quality oversight across computerized systems in regulated environments. Collaborate cross-functionally to enhance risk ma...

Drive the execution and management of clinical studies, ensuring compliance with quality standards and timelines. Collaborate with cross-functional teams while overseeing site monitoring and data inte...

Elevate clinical study execution by managing all phases of trials, ensuring quality compliance and stakeholder communication. Collaborate across teams to optimize diabetes care solutions through innov...

Join us to support quality systems and compliance in a medical device environment. Collaborate with cross-functional teams on validation and quality metrics ensuring product excellence in line with re...

Unlock your potential in this critical role overseeing validation protocols for medical devices. Collaborate cross-functionally to uphold quality standards, driving continuous improvement while ensuri...

Champion regulatory compliance in the APAC region by managing a team, developing strategies, and liaising with cross-functional teams to enhance Diabetes Care product portfolios and ensure adherence t...

Transform regulatory affairs in oncology by leading strategic submission initiatives and cross-functional collaborations, ensuring compliance and quality for impactful development programs. Drive regu...

Champion recall operations by managing teams, executing FDA-compliant strategies, and driving cross-functional alignment to ensure timely product corrections and removals while maintaining regulatory...

Develop your career with a dynamic role supporting quality assurance processes and compliance. Collaborate across teams to drive continuous improvement, oversee CAPA activities, and ensure readiness f...

Join a team that's driving patient access to groundbreaking gene therapy products. Leverage your expertise in health systems and reimbursement to educate stakeholders and facilitate timely product ava...

Lead cross-functional collaboration to establish regulatory strategies for drug development, ensuring compliance with ICH guidelines and global health authority requirements throughout product lifecyc...

Lead the charge in successful clinical trial management, ensuring compliance and alignment with regulatory standards while overseeing budgets and team performance across diverse therapeutic areas...

Unlock potential by driving technical sales in the gene therapy sphere, managing demos, and accelerating product adoption. Collaborate with Central Sales to convert opportunities and support long-term...

Lead compliance oversight and strategic management of contract manufacturing operations to ensure adherence to regulatory standards for complex clinical trials, while coordinating cross-functional tea...