Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Grow your career with a leadership role defining nonclinical drug safety strategies. Collaborate across functions to assess risks, promote innovative thinking, and drive decisions that impact therapeu...

Deliver innovative drug safety strategies across multiple therapeutic areas, driving cross-functional collaboration from discovery through to regulatory submissions. Lead risk assessments and shape pr...

Engineer innovative manufacturing solutions by enhancing processes, troubleshooting equipment, and collaborating with cross-functional teams to meet safety and quality standards while driving continuo...

Lead the QA team in driving quality excellence within a cGMP Cell Therapy environment. Oversee day-shift operations, coaching managers and ensuring compliance while enhancing team capabilities and sol...

Optimize automation solutions by collaborating across teams to enhance control systems for filtration products. Utilize hands-on engineering skills to ensure reliable performance in a regulated manufa...

Help us lead impactful Real World Evidence studies to enhance healthcare outcomes. You'll drive data analyses, collaborate cross-functionally, and act as a key analytics expert to ensure successful pr...

Join a team that's committed to excellence in clinical monitoring and site management. You will ensure compliance, manage documentation, and build relationships with investigational sites within a dyn...

Lead regulatory strategies for US promotional materials, ensuring compliance with FDA standards while collaborating across departments. Provide expertise for complex products, navigating regulatory la...

Empower mission success by leading systems engineering efforts for critical military projects, enhancing interconnectivity and effectiveness across air, maritime, and land domains through innovative d...

Champion project excellence by leading account management and ensuring quality, strategic execution while fostering client relationships and overseeing cross-functional teams to meet and exceed busine...

Drive analytical excellence by implementing AQbD principles, improving method robustness and lifecycle management. Lead cross-functional teams to align analytical practices with regulatory expectation...

Lead the high-quality monitoring of clinical trials, ensuring compliance with regulatory standards while managing site operations, training staff, and protecting participant safety in a fast-paced, dy...

Drive the design and lifecycle management of innovative drug delivery devices, collaborating with cross-functional teams to optimize strategies and ensure product success from development to market fo...

Join a team that drives quality excellence in the medical device industry. Oversee Quality Management Systems, lead a talented team, and ensure compliance with international regulations while fosterin...

Champion the creation of high-quality regulatory documents, managing writing tasks and leading reviews. Collaborate across teams to ensure clarity and compliance, mentoring junior writers while delive...

Drive impactful medical writing by leading regulatory documentation projects, ensuring clarity and compliance with standards, while collaborating across teams to deliver exceptional results and foster...

Lead IT Quality and Compliance initiatives for regulated clinical systems. Collaborate with diverse teams, ensuring compliance with FDA and EU standards while driving operational efficiency and suppor...

Engage in the leadership and integration of complex systems, ensuring compliance and robust solutions throughout the product lifecycle. Collaborate with cross-functional teams to define system require...

Accelerate innovative therapies by providing technical expertise, supporting sales, and ensuring seamless product adoption with customers in fluid management technology across the US region...

Join a team that drives innovative marketing strategies, enhances website development, and optimizes lead generation efforts across digital channels. Leverage creativity and analytics to increase bran...

Shape the internal audit function by leading assessments of key business processes. Collaborate closely with finance leadership to ensure compliance with US GAAP and enhance operational effectiveness...

Unlock potential by leading the mechanical design of advanced radar systems. Drive innovative solutions through all phases of product life cycle while collaborating closely with customers and ensuring...

Champion the strategic vision for Cell Culture, shaping market opportunities and growth paths in collaboration with cross-functional teams to achieve long-term financial goals and competitive position...

Champion global CAPA processes by providing expertise, conducting reviews, and enhancing quality standards across diverse teams, enabling continuous improvement and compliance in a remote environment...

Accelerate your career by providing vital procurement support in a collaborative environment. Engage with global teams and drive operational efficiencies while contributing to innovative projects in t...