Sr Director, Medical Device Regulatory Solutions
Company: IQVIA Holdings Inc
Posted on: June 12, 2021
IQVIA MedTech is seeking a Senior Director for our Medical
Device Regulatory Solutions division. Ideal candidates will
- 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
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.
- 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
- 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.
- Extensive use of telephone and face-to-face communication
requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of
- 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
IQVIA is an EEO Employer - Minorities/Females/Protected
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 email@example.com to arrange for such an
Keywords: IQVIA Holdings Inc, Tacoma , Sr Director, Medical Device Regulatory Solutions, Other , Tacoma, Washington
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