Senior Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Drive strategic acquisition policy research and support government initiatives while ensuring compliance with evolving regulations in a fast-paced environment...

Manage site operations ensuring efficient flow of information, training, and documentation within clinical research trials while collaborating with multiple departments to enhance trial execution and...

Drive quality assurance initiatives in medical devices by leveraging your expertise in ISO standards and regulatory compliance to ensure client products meet international benchmarks for safety and ef...

Join a dynamic team as you leverage your expertise in IVD device design to manage CE marking schemes, provide technical reviews, and support healthcare professionals in advancing patient safety throug...

Optimize records management processes by overseeing lifecycle management, compliance, and digital transformation initiatives. Enhance organizational effectiveness through strategic planning, policy de...

Manage the life-cycle of OSD records, ensuring compliance with federal regulations and optimal archival strategies while leading a team in records management initiatives and policy developments...

Manage the complete lifecycle of OSD records, ensuring compliance with federal regulations while leading program planning, records evaluations, and support for electronic records systems in a fast-pac...

Champion OSD records management lifecycle, ensuring compliance and accuracy while leading strategic initiatives for digital transition and efficient documentation processes in alignment with federal r...

Join us to lead product management of medical therapeutics, diagnostics, and clinical protocols. Engage in regulatory coordination with FDA and IRB. Drive IND accountability and support innovative sol...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Unlock innovative regulatory solutions as you lead global strategies to expedite product approvals, ensure compliance, and support cross-functional teams in navigating local and international regulato...

Drive transformative process improvement initiatives across disciplines, enhancing operational efficiency and reducing cycle times. Engage with executives and lead cross-functional teams to achieve me...

Elevate your career as a lead legal advisor for complex commercial contracts, fostering growth in MedSurg operations across the U.S. and Canada while ensuring compliance and strategic alignment with i...

Engage with clients and enhance product positioning by providing technical support, training, and marketing resources for GCMS operations. Collaborate with sales and marketing teams to address custome...

Empower digital transformation by shaping innovative strategies in Global Regulatory. Collaborate with cross-functional teams to leverage technology, optimize processes, and ensure compliance while le...

Advance your career by leading structural design projects, collaborating within multi-disciplined teams. Utilize 3D modeling tools to develop and troubleshoot structural designs while mentoring junior...

Champion innovative structural design solutions by collaborating with multi-disciplined teams, utilizing 3D modeling tools, and leading design phases to create efficient structural layouts for power p...

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

Support and manage construction project tasks, ensuring compliance and coordination with trades and contractors while overseeing budgets and schedules for efficient execution of operations at site loc...

Unlock potential by leading global regulatory strategies for immunology projects, ensuring compliance and optimizing product approvals. Collaborate with cross-functional teams and regulatory agencies...

Inspire high-level engagement in aviation acquisition. Collaborate with government clients, producing strategic briefings and analyses to streamline decision-making for air platforms and weapons. Driv...

Unlock potential by leading data integrity and automation initiatives in a cutting-edge bioproduction facility, enhancing operational efficiency and regulatory compliance while collaborating with cros...

Take ownership of complex validation projects, providing technical leadership and ensuring compliance for GMP manufacturing and R&D initiatives in a regulated environment. Drive continuous improvement...

Accelerate progress at a leading organization by shaping strategic initiatives and guiding executive teams. Drive impactful decisions through in-depth research and analysis, ensuring alignment around...

Lead the charge in clinical research by monitoring studies across various therapeutic areas, ensuring top-quality standards and effective communication with stakeholders while driving project timeline...