Sr. Regulatory Affairs Specialist

2 months ago

Lake Forest, United States STAAR Surgical Full time

This position can be remote for the right candidate who meets desired qualifications.


Job Overview

1. Plan, prepare and review all aspects of ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports.

2. Review/Prepare Standard Operating Procedures (SOPs).

3. Compile information necessary for periodic reports for Regulatory filings.

4. Preparation and maintenance of 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 and provide regulatory support when needed.

6. Review complex reports, validations, etc. for scientific merit and regulatory appropriateness.

7. Review proposed labeling to ensure that the intended use and claims are supported for use and domestic and international regulations are met.

8. Participate in/Support Health Authority Inspections.

9. Determination of regulatory submission requirements according to domestic and international regulations related to changes/new products/claims.

10. Maintain/Index/Organize Regulatory library.

11. Support for regulatory publishing including assembling, printing, quality checking, archiving of regulatory submissions and corresponding data.

12. Participate in compliance activities that relate to the department and the company as a whole.

13. Maintain technical knowledge of devices in area of responsibility.

14. Maintain up-to-date on global regulatory requirements.

15. Represent RA department in project meetings and provide regulatory guidance.

16. Provide training and mentorship to new hires as needed.

17. Other duties as assigned.


EDUCATION & TRAINING

• Bachelor of Science degree in a scientific related field. Advanced degree preferred.


EXPERIENCE

  • 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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