Vital Images, Inc., a Toshiba Medical
Systems Group Company, is a market leader in advanced visualization
software solutions for physicians and healthcare specialists. The
company's sophisticated technology gives radiologists, cardiologists,
oncologists and other medical specialists productivity and
communications tools that can be accessed throughout the enterprise
and via the Web at anytime and anywhere for patient care and
treatment planning. Vitrea® software has been installed at more
than 5,000 hospitals in over 80 countries. Established in 1988 and
headquartered in Minneapolis, Vital Images also has offices in Europe
and Asia. For more information, visit www.vitalimages.com.
BASIC PURPOSE AND OBJECTIVES:
Prepare U.S. and international
regulatory filings and registrations through significant work with
cross-functional teams. Ensure compliance with U.S. and international
regulations, standards and guidance. Assist with post-market review
of product issues and other projects in domestic and international
OVERALL OUTPUTS, DUTIES AND RESPONSIBILITIES:
• Prepare FDA and international submissions for new products
and product changes as required to ensure timely approval for market
release and in accordance with applicable regulations, standards and
• Lead and provide guidance to work teams
comprised of senior engineering and marketing personnel with regard
to regulatory planning and execution.
• Review and analyze
product complaints for appropriate domestic and international filings
as part of product post-market surveillance.
• Assist with
product hazard analyses.
• Advise technical, marketing and
sales personnel on regulatory requirements (e.g., Design Controls, CE
Marking, IDE, IRB, Labeling, Promotion).
guidance and review of product labeling, promotional material, change
control and other related product documentation.
Maintain database(s) for the worldwide regulatory status of products.
• Maintain regulatory affairs product files to support
compliance with requirements and standards.
• Assist with
regulatory audits from partners and external regulatory agencies
• May generate technical files and declarations of conformance
• Maintain the company’s Medical Device Listing and
Device Establishment registration forms.
execute and recommend modification to internal guidelines, work
• Monitor industry and
regulatory trends and develop strategy and provide guidance related
to such trends.
• Assist in various projects as assigned.
EDUCATION AND EXPERIENCE REQUIREMENTS:
• BA/BS degree
in engineering or life sciences
• At least two years of
progressive experience in domestic/international regulatory
submissions, design control systems and/or regulatory compliance.
• Experience with product registration requirements of U.S.
FDA (Class II) and countries outside the United States, including
European MDD (Class IIa), Asia, Middle East, Africa, Australia, South
America and Canada.
• Experience with IEC 62304 for
software lifecycle management preferred.
• Ability to
communicate complex ideas clearly and simply, orally and in writing.
• Ability to work on multiple concurrent tasks/activities
and meet corporate strategies.
• Ability to raise issues
with colleagues and managers in a proactive, professional manner and
drive win-win outcomes.
• Ability to build relationships
across functional boundaries at multiple levels.
technical, analytical and problem solving skills, including strong
project management skills.
• Ability to solicit feedback
and information from others in an open environment.
No unusual physical requirements
Regular business hours are Monday through
Friday, 8:00 a.m. to 5:00 p.m. Hours can vary and expand as dictated
by project demands.
We are an Equal Opportunity/Affirmative Action Employer
Vital Images - 16 months ago