Regulatory Affairs Specialist

3 days ago


San Antonio, Texas, United States Extremity Care Full time
Job Overview
As a key member of the Extremity Care team, the Regulatory Affairs Specialist will play a vital role in ensuring compliance with quality management systems and product realization. The successful candidate will possess strong knowledge of FDA and Health Canada regulations, excellent communication skills, and leadership abilities.

The Regulatory Affairs Specialist will facilitate accurate and timely approval of submissions by ensuring compliance with FDA and Health Canada regulations. They will interact with regulatory agency personnel to expedite approval of applications and responses to questions. Additionally, they will partner with Product Development, Marketing, and other cross-functional groups to compile technical information for regulatory submissions.

Responsibilities
  • Facilitate accurate and timely approval of submissions by ensuring compliance with FDA and Health Canada regulations.
  • Interact with regulatory agency personnel to expedite approval of applications and responses to questions.
  • Partner with Product Development, Marketing, and other cross-functional groups to compile technical information for regulatory submissions.
  • Support Marketing Material Development and Compliance with federal regulations.
  • Manage unique device identifiers (UDI) submissions and regulatory compliance.
  • Lead regulatory submissions for Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, International Registrations, etc.
  • Evaluate changes to regulatory documents and formulate strategies to maintain submission goals.
  • Maintain a working knowledge of relevant regulations and internal policies.
  • Participate in FDA and other regulatory agency inspections.
  • Review and approve proposed design and/or labeling changes to ensure international and domestic regulatory compliance.

Requirements
  • Bachelor's degree in a biological science or related field required.
  • Master's degree preferred.
  • At least 5 years of quality and/or regulatory experience in an FDA/MDR regulated environment for medical devices.
  • Clearance of favorable background investigation required.

Estimated Salary: $120,000 - $150,000 per year.

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