Regulatory Affairs Specialist

2 days ago

Lake Forest, California, United States STAAR Surgical Full time
Job Title: Sr. Regulatory Affairs Specialist

This is a remote opportunity for the right candidate who meets the desired qualifications.

Job Overview

We are seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team at STAAR Surgical. The successful candidate will be responsible for planning, preparing, and reviewing all aspects of ongoing and new regulatory submissions, both U.S. and international.

Key Responsibilities
  1. Plan, prepare, and review all aspects of ongoing and new regulatory submissions, including U.S. and international submissions.
  2. Review and prepare Standard Operating Procedures (SOPs).
  3. Compile information necessary for periodic reports for Regulatory filings.
  4. Prepare and maintain annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing.
  5. Collaborate with R&D, Clinical, Quality, Manufacturing, and Marketing teams to provide regulatory support.
  6. Review complex reports, validations, and other documents for scientific merit and regulatory appropriateness.
  7. Review proposed labeling to ensure compliance with domestic and international regulations.
  8. Participate in and support Health Authority Inspections.
  9. Determine regulatory submission requirements according to domestic and international regulations.
  10. Maintain and organize the Regulatory library.
  11. Support regulatory publishing, including assembling, printing, quality checking, and archiving of regulatory submissions and corresponding data.
  12. Participate in compliance activities related to the department and the company.
  13. Maintain technical knowledge of devices in the area of responsibility.
  14. Maintain up-to-date knowledge of global regulatory requirements.
  15. Represent the RA department in project meetings and provide regulatory guidance.
  16. Provide training and mentorship to new hires as needed.
Requirements
  • Bachelor of Science degree in a scientific related field. Advanced degree preferred.
  • Prefer 5+ years related experience.
  • Advertising and Promotion Review experience.
  • US Submission Experience (Class III).
  • EU/Canada/Latin America experience (Class III/IV).
Skills
  • Advertising and Promotion Review.
  • US Submission Experience (Class III).
  • EU/Canada/Latin America (Class III/IV).
  • Thorough understanding of FDA and international regulations.
  • Strong working knowledge of medical devices regulations and terminologies.
  • Excellent written and oral communication, and technical writing and editing skills.
  • Ability to write clear, understandable technical documentation.
  • Skilled at analyzing and summarizing data.
  • Proficient with Microsoft Office.
  • Ability to manage and prioritize multiple projects.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • Ability to work independently with minimal supervision.
  • Extreme attention to detail.
  • Ability to work in a team setting.

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