Director, Regulatory Affairs Jobs in Menlo Park, CA

Elevate regulatory processes by coordinating submissions for global approvals, ensuring compliance and facilitating access to vital healthcare technologies through meticulous documentation and project...

Lead strategic planning and execution of clinical research programs, managing multiple studies and partnerships with CROs and clinical sites to ensure adherence to regulatory standards and quality out...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

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...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Drive excellence in quality management by leading electronic systems and compliance initiatives, collaborating across diverse teams to enhance processes and continuously improve quality standards in t...

Pioneer regulatory strategies for innovative AI-driven medical solutions. Lead compliance activities and submissions, ensuring adherence to FDA standards while collaborating with cross-functional team...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Lead regulatory labeling activities to ensure compliance and clarity in product documentation. Collaborate with cross-functional teams while managing external partners, contributing to label design an...

Elevate your career by leading GMP Quality initiatives for clinical and commercial products. Oversee external manufacturing operations to ensure compliance, quality assurance, and timely supply while...

Drive successful execution of pivotal clinical trials, ensuring timely, compliant operations and data integrity. Collaborate cross-functionally to oversee study progress, vendor management, and regula...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

Oversee the healthcare compliance program, ensuring adherence to regulations and policies while conducting investigations, training, and audits to mitigate risks and enhance transparency across client...

Unlock potential by leading and executing a comprehensive risk-based Quality audit program, ensuring adherence to GxP regulations and Quality standards. Drive continuous improvement and regulatory rea...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

Join a team that's dedicated to securing regulatory approvals for innovative medical technologies, ensuring access to life-saving products worldwide while managing multiple submissions and collaborati...

Advance your career by overseeing all quality control aspects from drug development to commercialization. Lead a strategic, science-driven team in compliance with global regulations and ensure high-qu...

Transform the medical content strategy for a pivotal dermatology launch, ensuring accurate translation of clinical data into effective resources while collaborating across teams to prepare for a succe...

Lead critical PSPV compliance initiatives, ensuring adherence to regulations while guiding cross-functional teams through risk-based recommendations and quality improvements for safety standards withi...

Optimize quality compliance and risk management by leading GxP oversight, audits, and regulatory inspections to ensure organizational readiness and data integrity throughout late-stage development and...

Innovate by leading quality compliance and risk management initiatives. Collaborate with diverse teams to ensure inspection readiness, data integrity, and vendor oversight throughout late-stage develo...

Shape the future of regulatory strategy for critical products. Leverage your expertise to oversee local regulatory submissions and ensure compliance while collaborating with global teams to optimize p...

Innovate global regulatory strategies for complex clinical and CMC submissions. Collaborate with cross-functional teams while mentoring peers. This role requires both independent work and teamwork to...

Empower regulatory compliance within the 340B Program by interpreting complex regulations, advising internal teams, and ensuring operational readiness. Drive impactful educational initiatives and coll...

Join a team that's shaping regulatory strategy in a complex surgical platform. Engage with cross-functional teams to connect product design, clinical workflow, and quality standards, while representin...