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Clinical Regulatory Specialist, Device

Job description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Responsibilities include:

  • Prepare and analyze clinical data, journal articles and scientific presentations, as applicable, to support regulatory submissions
  • Manage one or more post-approval, post-market surveillance clinical trials
  • Develop clinical plan strategies and assist in the execution of clinical study protocols, timelines, and budget management
  • Collaborate with Regulatory and Quality Affairs on clinical data analysis and post-market surveillance
  • Support Marketing functions in strategic clinical data needs
  • Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures


  • 5+ years of experience as a Clinical Research Associate, Clinical Project Manager or equivalent external position
  • Experience in the medical device field preferred; experience in the pharmaceutical industry considered
  • Demonstrated clinical regulatory experience including knowledge of applicable US and OUS regulations and clinical data requirements, and preparation of clinical sections of regulatory submissions for FDA and international agencies.
  • Applied knowledge of project management tools
  • Demonstrated interpersonal, written and oral communication skills
  • Demonstrated organization and planning skills
  • Demonstrated success in a team-based environment preferred
  • Demonstrated knowledge and application of personal computer systems and desktop applications



Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at to arrange for such an accommodation.

Clinical Regulatory Specialist, Device

Columbus, OH
Full Time

Published on 06/20/2020