Senior Regulatory Affairs Specialist Jobs in Cambridge, MA

Lead the development of CMC regulatory strategies, ensuring successful product submissions and agency interactions. Collaborate with cross-functional teams to influence outcomes and maintain complianc...

Engage with key stakeholders to define CMC regulatory strategies, ensuring successful product delivery and first-pass approvals. Leverage expert insights to navigate complex submissions and foster str...

Elevate product development by leading formulation, process innovation, and manufacturing transfers. Collaborate across functions to enhance efficiencies and ensure compliance with FDA regulations whi...

Explore advanced imaging techniques to enhance case planning for TMTT therapies, enabling optimal procedural outcomes through collaborative analysis and training with the clinical team and healthcare...

Shape the future of quality assurance by leading technical strategies, driving compliance, and enhancing inspection methods in a dynamic aerospace and defense environment. Collaborate across teams to...

Join a dynamic team as an Associate Engineer, focusing on material characterization and testing. Contribute to innovative projects while gaining hands-on experience with cutting-edge automation techno...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...

Shape the future of medical device engineering by leading a skilled team in design controls, product reliability, and integration strategies for Class II/III coagulation programs, ensuring compliance...

Manage global clinical trials by leading teams and overseeing timelines, budgets, resources, and compliance. Ensure high-quality outcomes and adherence to regulatory standards while driving improvemen...

Shape the future of defense technology as a Senior Systems Engineer, bridging hardware, firmware, and cloud systems. Drive architecture, ensure coherent product integration, and own critical systems e...

Engage in the creation and coordination of Clinical Evaluation Plans and Reports, collaborating cross-functionally to ensure compliance with medical device regulations and drive innovation and quality...

Champion clinical trial success by leading site monitoring and management. Ensure high standards of patient care, compliance with protocols, and accurate data integrity through effective oversight and...

Join a team that engineers advanced sensor electronics to optimize designs for size, weight, and power. Develop architectures, perform simulations, and collaborate across disciplines to drive innovati...

Unlock insights as you champion financial analysis in healthcare reimbursement. Leverage your expertise to guide strategic decisions and optimize payer contracts while collaborating across teams to dr...

Join a team that's driving innovation in electronic engineering. Collaborate with cross-functional experts to design, test, and refine cutting-edge electronic systems that support national security mi...

Drive compliance strategy by managing IL4/IL5 offerings, ensuring regulatory adherence across AWS-hosted environments. Collaborate with security teams, federal regulators, and technical stakeholders t...

Engage in strategic sourcing for biochemicals, managing a $234m spend to optimize costs, quality, and supply chain continuity. Collaborate cross-functionally to drive innovation and sustainability in...

Engage with a dynamic CRO to oversee clinical monitoring and enhance site performance. Foster relationships, ensure compliance with regulations, and lead a team in delivering quality outcomes in clini...

Take ownership of validation activities for GMP equipment, ensuring compliance through protocol execution, documentation, and regulatory support while collaborating with cross-functional teams to enha...

Join a team that's dedicated to ensuring compliance through validation activities, including cleaning, equipment qualification, and troubleshooting. Play a pivotal role in maintaining high standards i...

Join a team that's revolutionizing user experience through code, prototyping, and shipping enterprise solutions. Collaborate across teams to design and optimize intuitive workflows, data visualization...

Elevate marketing initiatives within the Neuroscience team, driving key customer conversions through comprehensive tactical planning, collaboration, and training programs to achieve ambitious revenue...

Unlock potential by supporting project compliance tracking and permitting functions. Collaborate with agencies to ensure adherence to regulations while managing documentation and communication for con...

Unlock potential by advancing cutting-edge Vision-Language-Action models for robotics, pioneering research that bridges the gap between theory and real-world applications, and enhancing AI-driven robo...

Lead the charge in quality control for clinical and regulatory documents. Oversee QC reviews, ensure compliance with industry standards, and manage project timelines while mentoring a team and enhanci...