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Lead Specialist in Regulatory Compliance

2 months ago


Hopkins, Minnesota, United States Canon Medical Informatics Full time
POSITION OVERVIEW

Are you enthusiastic about regulatory compliance and medical technology? Join our team as a Lead Specialist in Regulatory Compliance at Canon Medical Informatics. In this pivotal role, you will spearhead U.S. pre-market activities, product strategy, and regulatory frameworks for medical software approval in the U.S.

KEY RESPONSIBILITIES
  • Formulate and execute regulatory strategies to ensure adherence to U.S. standards.
  • Facilitate pre-submission discussions with the FDA and manage HIT 510k applications.
  • Provide regulatory insights for product development and modification processes.
  • Prepare and submit necessary regulatory documentation to the FDA, ensuring prompt market access.
  • Collaborate with cross-functional teams to uphold quality management systems.
  • Evaluate marketing materials for regulatory adherence.
  • Assist in FDA communications and legal/regulatory matters.
  • Propose improvements for regulatory processes.
  • Examine competitors' regulatory submissions.
  • Advise on market entry criteria and clinical validation processes.
  • Engage in discussions with regulatory agencies and stay updated on industry developments.
  • Work alongside the EU regulatory team to ensure alignment.
REQUIREMENTS
  • Bachelor's Degree in Regulatory Affairs or Engineering Sciences; Master's degree is a plus.
  • A minimum of 4 years of experience in regulatory affairs within software, medical devices, or healthcare sectors.
  • Familiarity with FDA regulations, ISO standards, and legal frameworks relevant to medical device software.
  • Proven experience with FDA submissions and software lifecycle management.
  • Excellent communication and presentation abilities.
ABOUT CANON MEDICAL INFORMATICS

Canon Medical Informatics, a division of Canon Medical Systems Corporation, is at the forefront of health imaging informatics, creating cutting-edge solutions to enhance patient care worldwide. Our diverse team values innovation and collaboration, striving to make a significant impact on patient outcomes. Join us in a vibrant work environment that fosters growth and continuous learning.

OUR CORE VALUES

Unity, Courage, Tenacity, Teamwork, and Excellence.

WHAT WE OFFER

Become part of a team that provides competitive remuneration, a supportive atmosphere, and pathways for career advancement. Enjoy a relaxed work environment, flexible scheduling, and resources that promote work-life balance. Our facilities include amenities such as an onsite deli, fitness center, and wellness services.