Regulatory Affairs Specialist Jobs in Cambridge, MA

Shape the future of health technology by driving regulatory strategies for innovative lab testing, imaging, and AI products. Collaborate with cross-functional teams to ensure compliance and accelerate...

Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...

Elevate regulatory compliance by managing submissions for complex Class III medical devices. Collaborate with cross-functional teams to ensure adherence to US and international regulations while drivi...

Drive regulatory intelligence initiatives to ensure compliance and support clinical research. Collaborate with experts to assess regulatory changes, track global guidelines, and enhance impact assessm...

Transform regulatory strategies for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Lead complex submissions and collaborate across teams to drive successfu...

Lead the charge in regulatory consulting by delivering expert advice and strategies for clients navigating US, EU, and UK regulations. Manage projects independently, build client relationships, and me...

Lead the charge in global regulatory strategy for a late-stage immunology program, driving FDA interactions, submissions, and cross-functional decisions while shaping regulatory infrastructure in a dy...

Drive regulatory excellence by leading compliance strategies for medical devices, ensuring safety and effectiveness across global markets. Collaborate with cross-functional teams to embed regulatory r...

Drive your career with a pivotal role in CMC regulatory affairs, ensuring compliance for biologics and small molecules. Collaborate across teams to prepare high-quality submissions and strategies, imp...

Join a team that shapes global regulatory strategy in a fast-paced environment. You will lead comprehensive regulatory plans, ensuring alignment and execution from development to post-marketing, impac...

Join a team that's dedicated to ensuring compliance in global medical device registrations. You'll execute regulatory strategies, prepare essential documents, and collaborate with cross-functional tea...

Champion regulatory strategies to accelerate product approvals and compliance. Lead a dynamic team in supporting innovative medical devices, ensuring alignment with global regulations while fostering...

Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...

Optimize global regulatory activities for medical devices, ensuring compliance in labeling, UDI, and product data. Collaborate with cross-functional teams to support product registrations and maintain...

Transform the future of healthcare by coordinating regulatory submissions and strategies for innovative medical devices, ensuring compliance and supporting product lifecycle management in a dynamic en...

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

Drive regulatory strategy for early programs, leading cross-functional teams to ensure timely submissions to health agencies. Collaborate with global leads to navigate complex regulatory landscapes an...

Lead the charge in regulatory affairs by providing strategic guidance, ensuring compliance, and fostering collaboration across institutions. Drive initiatives from research to implementation while men...

Manage regulatory strategies for global product approvals, ensuring compliance and collaboration across teams. Lead submission activities for medical devices, fostering a high-performance culture whil...

Lead the development and execution of global regulatory strategies for pharmaceutical products, ensuring compliance and effective communication across teams. Drive operational excellence and foster re...

Lead the charge in managing pre-market regulatory activities to ensure compliance with US FDA, Health Canada, and EU IVD regulations. Collaborate with design teams, prepare submissions, and review pro...

Manage regulatory activities for advertising and promotion, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging and materials that align with com...

Join a dynamic team and take ownership of regulatory activities for various pharmaceutical products, providing guidance and ensuring compliance while collaborating with cross-functional teams across N...

Optimize quality systems in a dynamic GMP environment, ensuring compliance and supporting continuous improvement initiatives while collaborating across departments to enhance operational excellence...

Advance your career as a Quality Systems Specialist, ensuring compliance with GMP regulations and managing quality documentation. Collaborate across departments to drive continuous improvement in a dy...