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Regulatory Affairs Specialist

2 months ago

Washington, Washington, D.C., United States Lumicity Full time
Job Summary

Lumicity is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key Responsibilities
  • Regulatory Compliance: Develop and implement regulatory strategies to ensure compliance with US and international regulations.
  • Regulatory Submissions: Assist in the preparation and submission of EUAs, pre-submissions, and 510(k)s.
  • Product Registrations: Support international registrations, develop and maintain technical files, and prepare product dossiers.
  • Design History Files: Prepare and maintain Design History Files to ensure regulatory compliance.
  • Risk Management: Lead Risk Management efforts to identify and mitigate compliance risks.
  • Labeling and Marketing: Prepare and review labeling and marketing materials to ensure regulatory compliance.
  • Regulatory Strategies: Contribute to setting regulatory strategies for new product development.
  • Regulatory Updates: Stay updated on the latest regulatory requirements and trends.
  • Communication: Communicate with regulatory agencies regarding product submissions.
Requirements
  • Education: BS/MS in life sciences.
  • Experience: At least 3 years of experience in regulatory affairs.
  • Certification: Preferred certification in regulatory affairs.
  • Skills: Extensive knowledge of US and international regulations, exceptional written and verbal communication abilities, keen attention to detail, proficiency in technical systems, and capability to handle multiple projects.