Regulatory Specialist

Summary

The Regulatory Specialist is responsible for the implementation and oversight of Gold Standard Diagnostics’ Regulatory System, to improve compliance and operational efficiencies.

Essential Duties & Responsibilities

1. Preparation of regulatory documents or submissions for new products being developed and changes to current products
2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
3. Coordinate, prepare, or review regulatory submissions for domestic or international projects
4. Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures
5. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
6. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
7. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
8. Determine the types of regulatory submissions or internal documentation that are required for proposed device changes or labeling changes
9. Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
10. Prepare or coordinate the preparation of additional information or responses as requested by regulatory agencies
11. Prepare or maintain technical files as necessary to obtain and sustain product approval
12. Perform additional duties as assigned by supervisory or management personnel

Scope of Authority
Regulatory approval for DACF’s, reports and submissions