Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Transform your career by joining a dynamic team that evaluates renewable energy equipment compliance, develops test plans, and conducts rigorous testing on-site. Bring your engineering expertise to dr...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

Champion innovative quality solutions by supporting GxP operations and delivering actionable insights to leadership. Help ensure compliance and quality oversight in packaging validations, manufacturin...

Drive product quality and customer confidence by leading a team in quality investigations and continuous improvement initiatives, while fostering collaboration and accountability across functions to a...

Drive global regulatory strategies and leadership across development programs. Collaborate with teams to ensure regulatory compliance and successful filings with health authorities, providing mentorsh...

Join a team that drives excellence in hardware design integrity through effective collaboration, managing technical data package releases, and ensuring compliance for successful program execution...

Transform automation systems to enhance manufacturing processes, ensuring compliance and collaboration across teams. Lead implementation and support for innovative technologies that drive operational...

Shape the future of product communication by delivering expert regulatory guidance, collaborating across departments, and ensuring compliance with FDA regulations to support brand initiatives and prom...

Join a team that's dedicated to ensuring supplier quality across GMP operations. Oversee compliance, conduct audits, and track performance metrics to maintain the highest standards in quality assuranc...

Unlock your potential by coordinating analytical operations and driving process improvements. Collaborate with diverse teams to ensure timely, high-quality data management that supports innovative dru...

Advance your career by joining a team to qualify manufacturing and lab equipment at multi-use sites. Collaborate with internal and external partners to ensure compliance, support ongoing projects, and...

Collaborate with cross-functional teams to lead regulatory writing efforts, ensuring high-quality documentation throughout the drug development lifecycle, from preclinical to registration stages, to s...

Shape the future of healthcare technology by leading quality initiatives in the Endoscopy portfolio. Collaborate with cross-functional teams to drive innovative solutions, optimize processes, and enha...

Innovate with a team dedicated to transforming lab data processes, enhancing scientist experiences, and leveraging AI-driven insights. This high-impact role directs modernization efforts across global...

Lead the charge in analytical development for radiopharmaceuticals, providing strategic oversight and collaborative support to ensure compliance with GMP and regulatory standards throughout product de...

Join a team that's driving compliance excellence in supply chain operations. This role blends collaboration across Contracts, Legal, and Supply Chain, focusing on government contracting and ensuring r...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...

Lead the charge in ensuring high-quality medical devices by supporting compliance, conducting investigations, and driving process improvements in a dynamic manufacturing environment while enhancing qu...

Lead the charge in quality assurance initiatives, ensuring compliance with regulations and excellence in safety, medical, and regulatory quality across the product lifecycle, while collaborating with...

Manage reimbursement strategies supporting business goals across product areas. Collaborate with teams to guide product development, analyze landscapes, and educate stakeholders on reimbursement impac...

Elevate your impact as a process engineering SME, driving innovation and compliance in Drug Substance technologies within a global manufacturing network while collaborating with cross-functional teams...

Drive innovation in precursor development, optimizing manufacturing processes while ensuring compliance with regulatory standards to deliver high-quality radiopharmaceutical products for clinical and...

Join a dynamic team to lead regulatory project management, ensuring timely and compliant submissions to health authorities. Collaborate cross-functionally to align project goals, manage risks, and dri...

Manage site operations ensuring efficient flow of information, training, and documentation within clinical research trials while collaborating with multiple departments to enhance trial execution and...

Join a team that's dedicated to enhancing supplier quality in the medical device industry. This role focuses on compliance, audits, and continuous improvement initiatives, playing a vital part in deli...