Senior Regulatory Affairs Director, Medical Device (Home/Office-Based) - IQVIA Biotech (R1082461) in Morrisville, NC at IQVIA™

Date Posted: 7/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    7/11/2019
  • Job ID:
    R1082461

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.

BASIC FUNCTIONS:

To provide regulatory and quality support to select clinical research projects involving investigational or marketed medical device and diagnostic products or new medical procedures.  To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.

To support submission of applications to US or EU competent authorities, identification of the central Institutional Review Board (IRB), Ethics Committee (EC), and essential regulatory documents required for multiple global projects, development of Regulatory Document Management Plan, review of initial regulatory documents for site activation, and maintenance of internal CTMS for tracking study site status site initiation through study maintenance. Work directly with Global Head of Regulatory Affairs, Director of Clinical Monitoring, EVP, Clinical Operations, Project Managers and Clinical Trial Managers in execution of multiple regulatory affairs projects.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assist Global Head, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects in medical devices/diagnostics by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
  • Manage/oversee assembly and submission of applications to competent authorities.
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
  • Directs the performance of the regulatory affairs staff.  Develops project timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks.  Assesses performance and recommends salary adjustments.
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
  • Keep abreast of, interpret and communicate applicable regulatory agency regulations and statutes with internal departments and ensures IQVIA Biotech compliance. 
  • Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
  • Participates in business development activities to grow IQVIA Biotech business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation.
  • Perform other related duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Extensive knowledge of clinical research and product development life cycles for medical devices, diagnostics, combination products, and related products
  • Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international.
  • Robust experience in medical device regulatory affairs for class II and III devices and diagnostics in the US and ROW.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public. 
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Ability to read and synthesize technical material and to prepare clear and concise written documents.
  • Comprehensive knowledge of US Good Clinical Practice (GCP), ISO 14155-2011 (GCP), Good Manufacturing Practices (GMP), Quality Systems Management (ISO 13485) and Good Laboratory Practices (GLP) requirements,
  • Demonstrated experience in client service in the clinical research business.
  • Demonstrated high energy level.
  • Ability to handle multiple tasks and challenges simultaneously.
  • Demonstrated ability to form strong working relationships across functional boundaries.
  • Excellent written and verbal communication skills.
  • Excellent negotiation skills.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Ability and willingness to travel internationally.
  • Demonstrated ability to motivate, lead, and grow a regulatory affairs team.
  • Extensive demonstrated experience directing and supervising staff.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Ability to travel internationally for extended periods of time
  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • A minimum of 15 years of experience in clinical R&D and/or clinical research organizations focused on regulatory affairs; at least 10 years must be in medical device regulatory affairs.
  • Advanced degree in biomedical sciences and/or business management or comparable years of experience.
  • Excellent demonstrated knowledge of issues affecting regulatory affairs for clinical trials are required.
  • Excellent analytical and communication skills, particularly writing skills, are essential. 
  • Ability to travel both domestically and internationally is required.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1082461