Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Innovate regulatory strategies in a dynamic environment, managing compliance tasks, enhancing client services, and developing educational materials while ensuring adherence to global guidelines for cl...

Elevate your career as you ensure regulatory compliance in product development and manufacturing. Collaborate with project teams and guide submissions to domestic and international agencies while main...

Support cross-functional teams by providing regulatory guidance for IVD product development, developing strategies, and conducting risk assessments to ensure compliance with FDA and EU regulations for...

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Unlock your potential in a dynamic role overseeing regulatory affairs for drug development. Collaborate cross-functionally to shape regulatory strategies and ensure compliance with global guidelines w...

Join a team that's shaping global regulatory strategies for innovative medical devices. Leverage your expertise in Software as a Medical Device (SaMD) to make impactful submissions and ensure complian...

Join an innovative team as a Clinical Affairs Specialist, where you'll develop strategies, improve processes, and ensure compliance in a dynamic, supportive environment dedicated to advancing clinical...

Lead critical clinical strategies and ensure regulatory compliance while collaborating across teams to uphold data integrity and support product development initiatives in a dynamic environment...

Elevate regulatory compliance by analyzing drug quality databases, ensuring data integrity and FDA adherence. Collaborate with stakeholders to deliver actionable insights that enhance decision-making...

Drive global regulatory strategy for medical imaging products, ensuring compliance across the software development lifecycle. Lead a dynamic team, engaging with cross-functional partners and regulator...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Lead bioassay research and development for biotechnology products, focusing on assay validation and implementation. Collaborate on data-driven regulatory policies while managing research projects and...

Lead impactful initiatives in regulatory affairs within the chemical and environmental sectors. Collaborate with stakeholders, monitor policies, and communicate client priorities effectively to naviga...

Lead regulatory strategy for CAR-T and immunotherapy products, overseeing IND/IMPD and BLA submissions. Guide cross-functional teams, ensuring timely compliance and approvals while developing team mem...

Shape the future of regulatory affairs by driving product development and global registration strategies, collaborating with diverse teams to ensure compliance and efficiency throughout the product li...

Join a team that's passionate about advancing regulatory projects in the pharmaceutical industry. Drive compliance and ensure timely submissions while collaborating across functions, developing strate...

Champion global regulatory strategies by leading diverse teams in navigating complex approval processes for medical devices. Drive compliance and ensure optimal product launch pathways while addressin...

Empower your career by providing research support for evaluating protein drug stability. Collaborate on regulatory science initiatives while developing predictive methodologies to enhance the efficien...

Engage as a Global Regulatory Leader, driving innovative regulatory strategies and interactions to streamline product development and global approval processes, while ensuring compliance and effective...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

Drive organizational success by leading records management initiatives, conducting comprehensive assessments, and ensuring compliance with policies, all while enhancing data accessibility and protecti...

Transform the regulatory landscape by shaping product communications and ensuring compliance with FDA regulations. Guide promotional reviews, mentor team members, and navigate evolving regulatory chal...

Launch your career by supporting regulatory submissions and compliance activities, coordinating documentation, and engaging in team collaborations to drive successful outcomes in drug development and...

Partner with us to lead global regulatory affairs for innovative pharmaceutical products. Oversee strategy, team development, and agency negotiations while ensuring compliance and operational excellen...