Regulatory Affairs Specialist
Vital Images - Minnetonka, MN

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COMPANY OVERVIEW:
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 arenas.

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 guidance.
• 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).
• Provide 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.
• Interpret, execute and recommend modification to internal guidelines, work instructions, procedures.
• Monitor industry and regulatory trends and develop strategy and provide guidance related to such trends.
• Assist in various projects as assigned.
Requirements

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.
• Strong technical, analytical and problem solving skills, including strong project management skills.
• Ability to solicit feedback and information from others in an open environment.
PHYSICAL REQUIREMENTS:
No unusual physical requirements

WORKING CONDITIONS:
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 M/F/D/V

Vital Images - 15 months ago - save job - block
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