Regulatory Affairs Expert

6 hours ago


Reston, Virginia, United States Lumicity Full time

Key Qualifications and Skills:

  • A Bachelor's or Master's degree in life sciences, coupled with at least 3 years of experience in regulatory affairs.
  • Preferred certification in regulatory affairs.
  • Extensive knowledge of both US and international regulations.
  • Exceptional written and verbal communication abilities.
  • Keen attention to detail.
  • Proficiency in technical systems, including MS Office, SharePoint, statistical software, and online research.
  • Capability to handle multiple projects and meet deadlines.
  • Strong grasp of statistical analysis.
  • Skill in identifying compliance risks and escalating issues as needed.
  • Required experience in regulatory submissions, including pre-submissions, EUAs, 510(k)s, De Novo, and PMA.

Job Responsibilities:

  • Represent or lead Regulatory Affairs within project teams throughout the product lifecycle.
  • Draft and review protocols for analytical studies supporting regulatory submissions.
  • Assist in the preparation and submission of EUAs, pre-submissions, and 510(k)s.
  • Support international registrations, develop and maintain technical files, and prepare product dossiers.
  • Prepare and maintain Design History Files.
  • Lead Risk Management efforts.
  • Prepare and review labeling and marketing materials to ensure regulatory compliance.
  • Contribute to setting regulatory strategies for new product development.
  • Stay updated on the latest regulatory requirements and trends.
  • Communicate with the FDA and other regulatory agencies regarding product submissions.


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