Regulatory Affairs Manager Jobs in Rochester, NY

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...

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...

Tackle regulatory challenges by overseeing global quality compliance support, including managing audit logistics, controlled documents, training, and CAPA. Ensure adherence to quality standards while...

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...

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...

Champion a robust quality assurance program ensuring compliance and safety in product release, deviation management, and complaint resolution while leading a talented team and optimizing processes for...

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...

Join us to ensure quality compliance and drive continuous improvement by overseeing global quality investigations, facilitating stakeholder interactions, and implementing corrective actions based on r...

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

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...

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...

Unlock potential by leading global compliance initiatives for network security hardware, ensuring adherence to RF, EMC, safety, and cybersecurity regulations through effective cross-functional collabo...

Manage quality assurance processes supporting product commercialization, ensuring compliance with GMP standards. Lead audits, oversee documentation, and collaborate across teams to resolve quality iss...

Champion regulatory compliance excellence by operationalizing U.S. financial laws across lending, money transmission, and cryptocurrency sectors. Drive collaboration with diverse teams to implement ro...

Accelerate progress at the forefront of global regulatory affairs by leading strategies for IND/CTA approvals, ensuring product launches, and executing post-marketing initiatives in the oncology secto...

Transform regulatory practices by leading licensing projects and enhancing compliance frameworks. Collaborate with cross-functional teams to effectively manage commercial nuclear challenges and secure...

Lead the global GxP audit strategy and ensure quality compliance across R&D. Drive audit initiatives, manage risks, and cultivate a high-performing team to enhance quality culture and inspection readi...