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IQVIA Sr Director, Medical Device Regulatory Solutions in Madison, Wisconsin

IQVIA MedTech is seeking a Senior Director for our Medical Device Regulatory Solutions division. Ideal candidates will have:

  • 15+ years of Medical Device Experience

  • Prior FDA experience a plus

  • Prior Consulting experience preferred

  • Strong knowledge of and ability to lead projects in all stages of product lifecycle

Purpose

Strategically direct and lead planning and oversight of consulting services to achieve client expectations through the development, implementation, and delivery of regulatory consulting programs. Provide expertise, support, guidance, and advice to ensure client needs are met. Establish strategic goals and priorities and direct/oversee their delivery.

Responsibilities

  • Design and lead client engagements, and manage project deliverables including regulatory strategy assessments, regulatory plans, progress reports, presentations, premarket submissions, communications with regulatory authorities.

  • Partner with MedTech Clinical Solutions and other IQVIA business leads to manage project team. Adjust resources, deliverables and client expectations accordingly.

  • Lead, define, develop, and implement strategic plans to build MedTech Regulatory Solutions in the applicable program areas.

  • Responsible and accountable for results and for strategic planning of assigned engagements

  • Present relevant regulatory topics to industry clients and at professional conferences. Publish Go-to-Market materials such as slide decks, fact sheets, white papers.

  • Participate in Business Development, Marketing and Sales activities. Deliver business development/program presentation to prospective clients.

  • 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.

  • Serve as MedTech Regulatory Solutions liaison with other groups within IQVIA MedTech Clinical Solutions and IQVIA.

  • Meet competency proficiency for grade 180.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Sound knowledge of regulatory processes and requirements for all medical device and diagnostics classifications

  • 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree in life science-related discipline or related field and 15 years’ related experience or Master’s degree/MS/MBA with 10 years’ related experience; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech

  • Extensive use of keyboard requiring repetitive motion of fingers

  • Regular sitting for extended periods of time

Travel as required

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

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.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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