Regulatory Affairs Specialist Jobs in Gaithersburg, MD

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...

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...

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...

Innovate and execute regulatory CMC strategies for radiopharmaceutical products, ensuring compliance across global markets. Collaborate with cross-functional teams to support submissions and enhance p...

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...

Join a team that's dedicated to enhancing healthcare compliance. This role requires expertise in regulations and standards, managing projects, and fostering team growth while ensuring client facilitie...

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...

Join a team that's central to driving compliance in cosmetics and OTC products. You'll collaborate cross-functionally to support regulatory registration processes in the US and Canada, ensuring timely...

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...

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...

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...

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...

Shape the future of regulatory affairs by driving strategies for late-stage development programs. Collaborate across teams to ensure compliance, manage submissions, and support critical milestones in...