Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...

Drive human factors and usability engineering while supporting regulatory submissions. Collaborate with cross-functional teams to enhance product safety and compliance in bringing innovative medical t...

Shape the future of medical device safety by applying your expertise in quality management, risk assessment, and regulatory compliance while collaborating with cross-functional teams to ensure product...

Drive compliance excellence by overseeing regulatory adherence for complex benefit products. Collaborate with cross-functional teams, conduct risk assessments for innovations, and support escalations...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Accelerate your impact by winning high-value, complex opportunities through innovative workflow design and technical expertise, while shaping market direction and influencing strategic commercial deci...

Unlock the power of regulatory insights! Lead comprehensive monitoring and analysis of regulatory developments, providing actionable intelligence to guide business strategy and decision-making across...

Oversee innovative regulatory strategies to support transformative clinical programs. Collaborate with cross-functional teams to ensure the preparation of high-quality regulatory submissions while dri...

Optimize regulatory strategies for advertising and promotion, ensuring compliance with FDA guidance and contributing to cross-functional teams to enhance product messaging and educational materials, w...

Optimize compliance with cGMP by leading effective Quality Risk Management initiatives. Serve as a key expert, facilitating risk assessments and driving continuous improvements in quality systems and...

Serve as a strategic regulatory leader, guiding nonclinical drug development and ensuring compliance for successful clinical entry and regulatory submissions, collaborating with cross-functional teams...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Transform compliance through expertise in HR regulations, policy management, and training. Support a culture of accountability while navigating multi-state employment laws across diverse teams, ensuri...

Drive supplier quality assurance efforts to ensure compliance and meet performance standards. Manage supplier relationships, audits, and qualification processes for New Product Introductions while ove...

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

Transform compliance assurance through expert sterilization strategies, collaboration with cross-functional teams, and oversight of regulatory standards, ensuring quality and safety of medical devices...

Pioneer compliance in sterilization practices, ensuring adherence to global regulations. Collaborate with cross-functional teams to uphold standards in contamination control and validation across manu...

Join a team that's dedicated to advancing quality standards in medical device manufacturing. As a Senior Quality Engineer, you'll support component manufacturing through testing, validation, and colla...

Unlock quality assurance excellence by leading GxP documentation and training management. Enhance regulatory compliance and system efficiency in a cross-functional hybrid role within the pharmaceutica...

Shape the future of regulatory strategies by leading US regulations for product development while ensuring compliance and fostering collaboration across global teams for successful market access and p...

Join a team that's redefining US regulatory strategies for product development, ensuring accelerated patient access through innovative pathways. Collaborate cross-functionally to represent and lead re...

Drive your career by developing regulatory CMC strategies for biologics, authoring submissions, and collaborating with cross-functional teams to meet corporate objectives in a dynamic environment focu...

Lead the development and execution of US regulatory strategies, ensuring compliance and expedited pathways for innovative therapies. Collaborate with global teams and regulatory bodies to drive produc...

Oversee and enhance sterility assurance by designing and implementing Contamination Control Strategies aligned with regulatory standards. Collaborate closely with cross-functional teams to drive conti...