Senior Regulatory Affairs Specialist Jobs in Burlington, MA

Transform regulatory strategies to ensure compliance for innovative medical devices while collaborating with cross-functional teams on product development and clinical studies. Drive timely submission...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

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...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

Contribute to global compliance efforts by supporting regulatory strategies, preparing submissions, and coordinating with cross-functional teams to ensure adherence to international standards in a dyn...

Contribute to regulatory strategy by guiding cross-functional teams through product development, ensuring compliance with regulatory requirements for medical devices and AI technologies while facilita...

Join our dynamic team to lead international regulatory submissions for innovative digital health technologies, ensuring compliance across global markets and collaborating cross-functionally for succes...

Drive regulatory compliance by developing submissions and strategies for medical devices. Collaborate across teams to ensure timely approvals while adhering to global standards and practices in a dyna...

Deliver comprehensive regulatory submissions and ensure compliance with FDA and global standards. Contribute expertise in the medical device field while collaborating with cross-functional teams on in...

Lead global regulatory strategies for Class II robotics surgery devices, ensuring compliance throughout the product lifecycle. Collaborate with cross-functional teams in new product development and li...

Drive regulatory compliance initiatives for medical devices, ensuring successful submissions and approvals in domestic and international markets. Collaborate across teams to support product developmen...

Engage with a dynamic team to facilitate regulatory operations for novel therapeutics. Drive submissions to FDA/CVM while collaborating across multidisciplinary teams to set new regulatory standards i...

Champion quality systems transformation by enhancing documentation, investigations, and compliance processes. Drive continuous improvement and strengthen standards across operations to ensure clarity...

Lead global regulatory strategies for investigational products, coordinating submissions and navigating compliance. Collaborate across functions to deliver timely and accurate regulatory guidance, ens...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Champion regulatory compliance by managing global submissions, ensuring adherence to laws and guidelines. Collaborate across teams to develop strategies, optimize processes, and maintain effective age...

Take ownership of QA operations in radiopharmaceutical manufacturing, ensuring cGMP compliance, conducting audits, resolving quality events, and fostering a culture of continuous improvement within cr...

Champion innovative regulatory strategies for biopharma products, driving compliance and collaboration across teams to advance therapeutic development and ensure successful market entry...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Lead the charge in transforming global regulatory strategies into successful outcomes. Oversee regulatory activities and empower teams to ensure quality compliance, timely delivery, and robust cross-f...

Join a team that's shaping the future of active implantable medical devices by supporting clinical evaluations and regulatory submissions. Collaborate across disciplines to ensure compliance with EU a...

Unlock potential by leading regulatory compliance for advertising and promotional materials, guiding cross-functional teams in strategic initiatives, and ensuring adherence to industry standards and F...

Unlock potential by leading global regulatory CMC activities, developing strategies for product lifecycle management, and collaborating across teams to ensure successful agency submissions. Drive tran...

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...