Regulatory Affairs Manager Jobs in Bothell, WA

Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Champion compliance and innovation by advising cross-functional teams on FDA advertising regulations, driving strategic decisions to mitigate risks while supporting business objectives in healthcare c...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

Collaborate to lead regulatory projects, ensuring compliance with state and federal standards while enhancing internal processes and fostering strong stakeholder relationships for timely project compl...

Lead the charge in CQV activities for pharmaceutical manufacturing projects, ensuring compliance and managing extensive capital projects. Collaborate across teams, oversee execution, and support opera...

Shape the future of regulatory promotional operations by driving standards and streamlining review processes of promotional materials. Collaborate cross-functionally to ensure compliance and efficacy...

The Quality Risk Manager at Just Evotec Biologics is responsible for overseeing the quality risk program at the Redmond and Seattle sites, ensuring compliance with the Just Pharmaceutical Quality Syst...

The Quality Risk Manager at Just Evotec Biologics is responsible for overseeing the quality risk program at the Redmond and Seattle sites, ensuring compliance with the Just Pharmaceutical Quality Syst...

Join a dynamic team as you lead GxP compliance initiatives across global pharmaceutical operations, ensuring adherence to US-FDA regulations. Drive improvements in quality systems and prepare faciliti...

Contribute to enterprise leadership in product safety risk management, ensuring compliance and aligned processes throughout the medical imaging software product lifecycle, and leading a team of safety...

Contribute to building a robust regulatory framework by overseeing compliance controls, driving change management, and collaborating across teams to ensure effective governance and operations in a dyn...

Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...

Build impactful relationships with state healthcare regulators to enhance operational efficiency and compliance. Leverage consultative skills to drive multi-year contracts and strategic partnerships...

Lead early phase clinical trials, ensuring operational excellence and project delivery. Manage sponsor relationships, oversee project finances, and guide teams to successful execution in compliance wi...

Shape regulatory compliance strategies by overseeing "Grape to Bottle" and "Bottle to Market" frameworks. Collaborate with teams to ensure accurate reporting, streamline workflows, and support interna...

Lead compliance initiatives and provide strategic guidance on government contract accounting and regulations. Ensure adherence to DFAR, FAR, and CAS, while managing audits and supporting the organizat...

Lead regulatory initiatives and ensure compliance for nuclear projects, leveraging 5+ years of experience in licensing. Collaborate cross-functionally to drive complex projects and deliver effective d...

Lead compliance initiatives in biologics manufacturing, ensuring cGMP adherence while supervising a dynamic team. Drive quality improvements, enhance technical capabilities, and engage in audits to de...

Collaborate with toxicology program leaders to oversee study design, execution, and data interpretation, ensuring adherence to safety protocols and operational goals. Drive excellence in study monitor...

Optimize global regulatory product planning to drive alignment and readiness across obesity assets. Collaborate with cross-functional teams to identify risks, manage milestones, and support execution...