Regulatory Affairs Specialist

2 days ago


Irvine, California, United States Planet Pharma Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Planet Pharma. As a key member of our regulatory team, you will be responsible for ensuring compliance with global regulatory requirements for medical devices.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with global regulations, including FDA, EU, and other international regulatory agencies.
  • Prepare and submit regulatory documents, including 510(k) applications, PMA applications, and EU CE marking applications.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure regulatory compliance throughout the product lifecycle.
  • Provide guidance and training to internal stakeholders on regulatory requirements and best practices.
  • Stay up-to-date with changing regulatory requirements and industry trends, and implement process improvements as needed.
Requirements
  • Bachelor's degree in a scientific discipline, such as biology, microbiology, or chemistry.
  • 5-7 years of experience in regulatory affairs, with a focus on medical devices.
  • Proven expertise in Microsoft Office Suite, including Word, PowerPoint, and Excel.
  • Excellent written and verbal communication skills, with the ability to effectively communicate with internal and external stakeholders.
  • Strong analytical and problem-solving skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
What We Offer

We offer a competitive salary range of $40-48/hour, commensurate with experience. Our company culture values collaboration, innovation, and continuous learning, and we offer opportunities for professional growth and development.



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