Director, Regulatory Affairs (Companion Diagnostics and IVD) (R1082611) - Durham, NC - IQVIA™

Date de publication 8/30/2019

Résumé de l'offre

  • Type d'employé
    CDI / CNE
  • Expérience
    Not Specified
  • Date de publication
  • Job ID:

Description de l'offre

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.


  • Lead all Regulatory communications with FDA and international competent authorities including authoring Pre-IDE, Risk Assessment, IDE and PMA submissions.
  • Lead Regulatory interactions with EU competent authorities to ensure alignment with present CE marking Self Certification and future EU IVD Directives.
  • Working with internal QA, participate in the development, design and implementation of a QSR system at Q2 Solutions.
  • Keep abreast of changing global Regulatory landscapes pertaining to Companion Diagnostics and IVD and make recommendations to the Business to ensure compliance and training.
  • Provide input to early Engagement with Pharma, BioTech, and IVD manufacturers on appropriate Regulatory strategy to enhance our Business Development Solutions to help secure CDx, IVD and Precision Medicine business for Q2.
  • As required, provide Regulatory Capabilities advice and expertise at Bid Defense and other client facing meetings. Accordingly, some internal and occasional international travel will be required – 5-10%.
  • Contribute to the development of internal and/or external communications including Insight briefs, White papers, and capability slide decks.
  • Work with strategic pricing and Operations to develop appropriate pricing/ rate card for Regulatory Services that Q2 offers.


  • BA/BS required; MBA and/or MPH is strongly preferred. A minimum 8–10 years of Regulatory Affairs experience with at least 5+ years of experience in IVD and or CDx development of working with CDRH in a diagnostic company, Pharma industry or Central laboratory. 


  • In depth Regulatory background in Companion Diagnostics development and a working knowledge of drug development across all stages of development. 
  • In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
  • Strong understanding of industry trends as well as Regulatory paths for Companion Diagnostics in vitro diagnostics in US, Europe, Japan and other major markets. 
  • Strong leadership experience with ability to set priorities, direct projects and implement complex strategies and work on cross-functional teams.
  • Excellent written and oral communication skills
  • Excellent client management and problem resolution skills
  • High ethical standards
  • Ability to assess and prioritize multiple tasks, projects and demands
  • Ability to make effective and persuasive presentations on complex topics to clients, senior management and other stakeholders
  • Demonstrate strong leadership skills, can lead by example with a high level of intelligence, and be dedicated to working collaboratively with other functional groups. 

EEO Minorities/Females/Protected Veterans/Disabled

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.

Job ID: R1082611