Skip to main content

Associate Principal Medical Device Regulatory Solutions, Home-Based USA

Apply now
Primary Location: Morrisville, North Carolina, United States Additonal Locations: Baton Rouge, LA,USA; Chicago, IL,USA; Collegeville, PA,USA; Columbus, OH,USA; Dallas, TX,USA; Dayton, OH,USA; Jacksonvile, FL,USA; Kansas City, KS,USA; New York, NY,USA; Portland, Oregon, United States,USA; Richmond, VA,USA; Sacramento, CA,USA; San Francisco , CA,USA; Seattle , WA,USA; Stamford, CT,USA; Tacoma, WA,USA Full time R1240327

Job description

JOB OVERVIEW
Manages multiple MedTech Regulatory consulting projects of varying complexity and ensures on-time and on-budget delivery for clients in MedTech or related industries. Serves as point person on engagements. Contributes to new business development and maintaining and strengthening client base.

ESSENTIAL FUNCTIONS

  • Define and implement regulatory strategic plans in the applicable program areas
  • Manage project deliverables including regulatory strategy assessments, regulatory plans, progress reports, presentations, premarket submissions, communications with regulatory authorities. Adjust resources, deliverables and client expectations accordingly.
  • Leverages business experience and acumen in identifying strategic alternatives and project approach to client questions.
  • Serves as key point of contact with client.
  • Provides follow-up with client after project deliverable has been completed to ensure client satisfaction.
  • Monitor project time charges within the functional group.
  • Manages project teams/staff including both internal and external resources, when applicable, in the design, development and delivery of client deliverables.
  • Ensures clear communication throughout projects and within the team.
  • Supports the development of intellectual property for use on future engagements.
  • May manage the process of proposal preparation and/or modifications including overall bid integrity.
  • Develops and/or elevates new business opportunities through the identification of follow-on work and new leads.
  • Develops broader and deeper knowledge of consulting methodologies and MedTech market through on the job experience and training.
  • Provides direction, advice and intellectual leadership to clients and delivery teams.
  • Directs consulting teams through consistent participation in team meetings.
  • Provides high level input to, and ensures the development of, client reports and presentations and delivery of all or significant portions of findings to client.
  • Maintain proficiency of skills and knowledge and remain current with industry trends based on current literature, regulatory guidance documents, application of new technology, attendance at professional meetings, etc.
  • May present relevant regulatory topics to industry clients and at professional conferences. Publish materials such as fact sheets, white papers.
  • Shares subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.
  • Leads ad hoc work streams on critical people-related issues such as recruitment, learning and development.
  • May serve as a coach to junior staff.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Sound knowledge of regulatory processes and requirements for all medical device and diagnostics classifications
  • Sound knowledge and understanding of FDA and Health Canada submission processes
  • Project planning methodology, problem analysis, development and technical writing for marketing applications and communications with regulatory authorities
  • Strong influencing and negotiation skills.
  • Strong interpersonal and organizational skills.
  • Excellent verbal and written communication skills.
  • Ability to lead, guide and motivate project team members to achieve desired results.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

QUALIFICATIONS

  • Bachelor's Degree in life science related discipline or related field [Req]
  • Master’s Degree/ MBA or Higher degree [Pref]
  • 8-10 years professional experience in consulting, MedTech and/or healthcare industry with evidence of career progression [Req]
  • Demonstrable experience in and commitment to the life sciences and/or healthcare industries.
  • A track record of leadership and people development.
  • A willingness and ability to travel.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.

Apply now

Join IQVIA’s Talent Network

Let’s stay connected. Join our global Talent Network to receive alerts when new opportunities become available that match your career ambitions.

Join our network
Top of page