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Regulatory Compliance Specialist

2 months ago

Irvine, California, United States Jobot Full time

Join a Leading Medical Device Company as a Regulatory Affairs Specialist
About the Role:

We are seeking a talented and experienced Regulatory Affairs Specialist to become a vital part of our team within the medical device sector. This role is essential in maintaining our compliance with various domestic and international regulations, guidelines, and standards.


Why Work With Us?

We offer competitive compensation, comprehensive benefits, and a supportive work-life balance.


Key Responsibilities:
  • Prepare and submit regulatory documentation, including 510k submissions, PMAs, and other regulatory applications to the FDA and relevant authorities.
  • Ensure that all products and processes comply with applicable regulations and standards.
  • Contribute to the formulation and execution of regulatory strategies for new and modified products.
  • Review and approve product labeling and promotional materials to guarantee regulatory compliance.
  • Engage with regulatory agencies and represent the company during inspections and meetings.
  • Provide regulatory insights and guidance to cross-functional teams, ensuring that regulatory requirements are integrated into project goals.
  • Stay informed about changes in the regulatory environment and communicate their implications to internal teams.

Qualifications:

The ideal candidate will possess:

  • A Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • At least 2 years of experience in Regulatory Affairs within the Engineering or Medical Device sector.
  • Demonstrated experience with 510k submissions, PMAs, and other regulatory applications.
  • A solid understanding of Class III Medical Devices.
  • Strong knowledge of relevant domestic and international regulations and standards.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments.
  • Strong analytical and problem-solving abilities, capable of interpreting and applying regulatory guidelines.
  • Proficiency in Microsoft Office Suite, particularly in managing regulatory documentation.
  • The ability to work autonomously, manage multiple projects, and meet deadlines.

If you are a strategic thinker with a robust regulatory background and a passion for the medical device industry, we encourage you to consider this opportunity.