Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Champion quality assurance practices by enhancing project controls, ensuring regulatory compliance, and conducting inspections across engineering and construction activities for nuclear energy and com...

Join a dynamic team to manage global clinical trial budgeting and contracts, ensuring smooth startup and financial performance across international sites while collaborating with various operational a...

Explore opportunities as a Clinical & Regulatory Information Management SME, supporting client delivery across VeevaRIM and Clinical initiatives. Engage with stakeholders, optimize processes, and enha...

Unlock potential in medical device innovation through regulatory leadership. Drive compliance and approvals by collaborating with cross-functional teams to optimize strategies and influence successful...

Drive regulatory strategy for innovative mRNA products in oncology and rare diseases, navigating complex landscapes to ensure successful product development and approvals. Collaborate cross-functional...

Empower compliance and quality in aseptic manufacturing by driving sterility assurance initiatives, overseeing operational improvements, and serving as a subject matter expert, ensuring adherence to r...

Join a dynamic team to oversee CAPA activities, enhance quality compliance, and drive continuous improvements in a regulated environment. Collaborate across functions to ensure timely and effective re...

Unlock potential by leading test and evaluation strategies for defense projects. Collaborate with teams to develop, execute, and report on test processes that ensure mission success and software relia...

Drive your career forward by leading a multi-disciplinary team in sustaining engineering for medical devices. Oversee compliance, design improvements, and operational excellence while fostering a cult...

Join a dynamic team to lead strategic regulatory CMC initiatives, enhancing biopharmaceutical product development. Drive impactful CMC efforts for biologics, ensuring compliance and facilitating succe...

Elevate product quality by managing supplier evaluations and risk assessments. Implement effective quality systems and audit compliance to ensure manufacturers meet stringent standards for excellence...

Join a dynamic team to enhance manufacturing processes using Lean and Six Sigma methodologies. Drive process improvements in the medical device industry while ensuring compliance with regulatory stand...

Elevate global regulatory strategies as you lead cross-functional teams, ensuring compliance while driving market access for innovative products. Collaborate with stakeholders and health authorities t...

Unlock regulatory innovation in the biotech space, driving strategies for I&I therapeutics. Collaborate with cross-functional teams to navigate IND to BLA/NDA submissions, ensuring alignment with glob...

Transform quality compliance through strategic leadership and oversight. Own global quality compliance programs, ensuring regulatory alignment and fostering a proactive risk-based culture that support...

Lead software design quality initiatives for innovative IVD medical devices, integrating risk management and regulatory compliance throughout the development lifecycle to enhance diagnostic accuracy a...

Empower quality assurance initiatives by overseeing GMP activities and collaborating with cross-functional teams to ensure compliance and quality in clinical and commercial products. Drive success in...

Champion global access programs for innovative cancer therapies, ensuring alignment with clinical, regulatory, and patient needs. Lead cross-functional teams to enhance early access strategy and opera...

Lead strategic initiatives at the nexus of regulatory and scientific affairs, enhancing technology solutions to drive compliance and evidence generation while fostering partnerships across R&D, IT, an...

Transform clinical trial operations by managing global studies, coordinating teams, and ensuring compliance with protocols and regulations. Collaborate with cross-functional groups to deliver on proje...

Elevate compliance and revenue integrity across health plans, ensuring adherence to regulations. Collaborate with legal, finance, and operations teams to drive operational efficiency and embed privacy...

Innovate quality assurance processes by driving compliance in commissioning, qualification, and validation activities within the biopharmaceutical sector, ensuring adherence to industry standards and...

Help us optimize manufacturing processes as a Senior Product Engineer, collaborating cross-functionally to enhance product performance, ensure quality, and drive innovation from conception through del...

Lead the future of clinical trials by managing complex programs across US and EU regions. Drive collaboration, ensure compliance, and oversee all aspects of study execution from planning through close...

Lead the lifecycle management of complex subcontracts for government and commercial aerospace programs. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and ef...