Regulatory Affairs Director

1 week ago


San Antonio, Texas, United States Extremity Care Full time
Director of Regulatory Affairs

At Extremity Care, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. This key role will be responsible for overseeing all regulatory matters, ensuring compliance with FDA and state requirements, AATB Standards, ISO Standards, and other applicable regulations.

Key Responsibilities:
  • Create and implement regulatory strategies and solutions to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
  • Support organizational strategic objectives and facilitate external audits.
  • Serve as primary regulatory contact for the organization and maintain effective relationships with regulatory agencies.
  • Perform and/or oversee regulatory review of procedures, marketing, and sales promotional label/labeling materials.
  • Author/revise procedures according to FDA, AATB, and other regulations.
  • Oversee management of and/or support submissions of FDA/AATB reportable events.
  • Direct and oversee management of state license application submissions and renewals.
  • Oversee management of unique device identifiers (UDI) submissions and renewals.
  • Lead, support, and/or oversee development and maintenance of design control, risk management, and other relevant procedures.
  • Provide regulatory guidance on case studies and clinical studies.
  • Provide regulatory support on research manuscripts and white papers.
  • Direct and oversee monitoring program for regulatory updates and internal compliance evaluation.
  • Monitor FDA activities and analyze and report on company impact.
Requirements:
  • Bachelor's degree in biological science or related field required. Master's degree preferred.
  • At least years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience.
What We Offer:
  • Opportunity to work with a dynamic team in a fast-paced environment.
  • Competitive salary and benefits package.
  • Professional development opportunities.


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