Regulatory Affairs Specialist- Irvine

1 month ago


Irvine, United States Hydrogen Group Full time

Are you passionate about navigating global regulatory landscapes and ensuring the compliance of life-saving medical devices? We're looking for a skilled Regulatory Affairs Specialist to join a vibrant team in Irvine, CA

This medical device company are pioneering innovative medical solutions that enhance patient care worldwide. Their International Regulatory Affairs team plays a crucial role in shepherding products through the regulatory process, working closely with in-country representatives to secure approvals and clearances.

Pay Rate Range: $44-$49 per hour

Location: Irvine, CA (100% onsite)

Duration: 8 month contract

Key Responsibilities:

  • Develop and maintain regulatory submissions for product approvals and clearances, collaborating with overseas affiliates.
  • Provide strategic guidance on regulatory pathways and contingency planning for international markets.
  • Represent the regulatory function on cross-functional teams, ensuring alignment with global regulations.
  • Collaborate with business unit teams to navigate registration requirements, product changes, and process enhancements.
  • Additional duties as assigned by leadership.

Requirements:

  • Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • 5-7 years of experience in regulatory affairs within the medical device industry.
  • Proficiency in Microsoft Office Suite, particularly Excel for data analysis and reporting.
  • Strong understanding of international regulatory standards for medical devices, including Class II and/or Class III.
  • Experience with regulatory submissions and documentation, including Design History Files.
  • Meticulous attention to detail and ability to manage competing priorities in a fast-paced environment.

Please apply with an updated resume to be considered

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