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Regulatory Affairs Consultant

2 months ago

Irvine, California, United States Jobot Full time

Join a reputable medical device organization as a Regulatory Affairs Specialist
This opportunity is hosted by Jobot.

Compensation:
$80,000 - $95,000 annually

About Us:


We are a leading manufacturer in the medical device sector, seeking a Regulatory Affairs Specialist to enhance our team. Candidates with experience in Class II/III medical devices are encouraged to apply.


Why Consider Us?
We offer competitive compensation, comprehensive benefits, and a balanced work-life environment.

Position Overview:

Key Responsibilities:


As a Regulatory Affairs Specialist, you will play a vital role in ensuring compliance with relevant domestic and international regulations, guidelines, and standards.

Your responsibilities will include:

  • Preparing and submitting regulatory documentation, including 510k submissions, PMAs, and other regulatory applications to the FDA and other authorities.
  • Ensuring compliance of products and processes with applicable regulations and standards.
  • Contributing to the development and execution of regulatory strategies for new and modified products.
  • Reviewing and approving product labeling and promotional materials to ensure adherence to regulatory requirements.
  • Engaging with regulatory agencies and representing the organization during inspections and meetings.
  • Providing regulatory insights and guidance to cross-functional teams, ensuring regulatory considerations are integrated into project goals.
  • Staying informed on regulatory changes and communicating 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 sectors.
  • Demonstrated experience with 510k submissions, PMAs, and other regulatory applications.
  • Strong understanding of Class III Medical Devices.
  • In-depth knowledge of domestic and international regulations and standards related to the Medical Device industry.
  • Excellent communication and interpersonal skills, capable of effectively collaborating with various departments and regulatory bodies.
  • Strong analytical and problem-solving abilities, with a knack for interpreting and applying regulatory guidelines.
  • Proficiency in Microsoft Office Suite, particularly in managing regulatory documentation and reports.
  • Ability to work autonomously, manage multiple projects, and meet deadlines.


If you are a strategic thinker with a solid regulatory background and a passion for the medical device industry, we invite you to explore this opportunity.