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Regulatory Affairs Specialist - Minnetonka

Employer
Vital Images
Location
Minnetonka
Salary
Competitive

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Job Details Description COMPANY OVERVIEW

At Vital, what we do matters. This is at the heart of every product we develop, every service we provide, and especially each member of our team. Vital is part of Canon Medical Systems, and together we lead the industry with the latest health imaging informatics solutions. We improve the quality of patient care by developing innovative products that enable the exchange, analysis and storage of clinical information across health care enterprises and communities. Our products handle millions of medical images and health records a day across the world. Vital Images experiences the best of both worlds with a dynamic and collaborative environment, casual culture, and agility of a mid-sized company, while having the support and resources of Canon.

Our offices are based in Minnetonka, Minnesota; Waterloo, Ontario; Copenhagen, Denmark; The Netherlands; and Beijing, China. We value our team's innovation, enthusiasm, and dedication to help improve the lives of patients. Do you want to be part of a passionate team that believes what we do matters? Then a career with Vital Images might be right for you!

POSITION OVERVIEW 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. 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 regarding regulatory planning and execution. Review and analyze product complaints for appropriate domestic and international filings as part of product post-market surveillance. 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. Interpret, execute and recommend modification to internal guidelines, work instructions, procedures. Assist in various projects as assigned. REQUIREMENTS 2+ 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, Japan and Canada.
  • Ability to build relationships across functional boundaries at multiple levels
  • Strong technical, analytical and problem-solving skills and project management skills
  • JOB COMPETENCIES
  • Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs.
  • Global Perspective - Has a global view and is comfortable and effective working with global partners, understands global markets and international considerations.
  • Listening Skills - Listens attentively to others, asks clarifying questions, actively listens, stays open to other viewpoints, manages distractions and interruptions.
  • Quality Work - Is attentive to detail and accuracy, is committed to excellence, looks for improvements continuously, monitors quality levels, finds root cause of quality problems, owns/acts on quality problems.
  • Research/Information Finding - Finds needed data through known sources; has good contacts or source knowledge; uses resourcefulness to tap as-yet-unknown sources; identifies, sorts and categorizes source materials to deliver most pertinent information.
  • COMPANY VALUES

    Integrity, Customer Focused, Collaborative, Problem Solvers, Drive

    WHAT WE OFFER YOU

    Vital offers a dynamic work place, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you'll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn't sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. In our office of 170, we have free healthy snacks, a deli on site and Friday massages. Our team at Vital loves what we do and has fun doing it together. We look forward to receiving an application from you.

    This position is based in our Minnetonka, MN office.

    Vital is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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