Regulatory Affairs Professional

3 weeks ago


Sunnyvale, California, United States IntelliPro Group Inc. Full time
Job Overview

At IntelliPro Group Inc., we are seeking a highly skilled Regulatory Affairs Professional to join our team. This role will be responsible for overseeing the regulatory aspects of medical device development and market introduction.

Key Responsibilities:

  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Develop and maintain an ISO 13485 and FDA-compliant Quality Management System.
  • Prepare and review regulatory submissions to the US FDA and international regulatory authorities.
  • Support government interactions related to medical device registrations and licensing.
  • Contribute to the development of regional regulatory strategies and update strategies based on regulatory changes.

About the Role:

  • Bachelor's degree in Science, Engineering, Math, or a medical field.
  • Minimum 5 years of experience in medical device Regulatory Affairs.
  • Demonstrated ability to manage small projects and display exceptional organization skills.

Estimated Salary: $120,000 - $200,000 per annum.

Benefits:

  • Comprehensive benefits package.
  • Ongoing training and professional development opportunities.


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