Regulatory Affairs Manager Jobs in Gaithersburg, MD

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...

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...

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...

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...

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...

Unlock your leadership potential by guiding a dynamic software engineering team. Collaborate with cross-functional teams to develop cutting-edge products while ensuring technical excellence and foster...

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

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...

Drive quality assurance for new product introductions in pharmaceuticals. Leverage leadership skills, manage cross-functional teams, and ensure regulatory compliance to deliver high-quality products e...

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...

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...

Optimize CMC regulatory strategies for biologic products across the product lifecycle. Lead cross-functional teams to ensure compliance with global regulatory standards while driving successful submis...

Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...

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...

Lead the charge in developing and overseeing global product labeling strategies for Neuromodulation therapies, ensuring compliance with regulatory standards, and fostering cross-functional collaborati...

Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...

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...

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...

Join a dynamic team to facilitate regulatory document preparation and submission, ensuring compliance as you support U.S. regulatory activities and collaborate with cross-functional teams to execute s...

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...

Reimagine legislative engagement as a Senior Manager guiding policy and funding strategies for advanced nuclear deployments. Collaborate cross-functionally to influence congressional priorities and se...

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

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...

Engage in leading GCP audit programs, managing staff development, and implementing quality initiatives to enhance safety compliance. Contribute to a dynamic, science-focused environment dedicated to i...

Elevate business development for a regulatory practice through strategic planning, team management, and client engagement. Drive revenue growth and ensure operational excellence by innovating practice...