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Regulatory Affairs Director

1 month ago

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

At Extremity Care, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for ensuring compliance with FDA and state regulations, as well as maintaining effective relationships with regulatory agencies.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with FDA and state regulations.
  • Support organizational strategic objectives and facilitate external audits.
  • Collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
  • 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.
  • Lead, manage, and develop regulatory pathways for new product development projects.
  • Support development of qualification/validation protocols and verify compliance with regulatory requirements.
  • 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.
  • Collaborate with Product Development and Management to establish and support project timelines.
  • Provide regulatory oversight, support, and approval for new projects and products.
  • Integrate shared leadership and foster collaboration across multi-disciplinary teams.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations policies and procedures.
  • File and maintain records in accordance with standard operating procedures.
  • Manage direct reports and establish and monitor objective annual goals.
  • Conduct performance reviews and establish performance improvement plans as needed.
  • Recruit, interview, and select personnel for hire.
  • Travel domestically and internationally up to 10% to attend offsite meetings, conferences, and support business initiatives.
Requirements:
  • Bachelor's degree in biological science or related field required.
  • Master's degree preferred.
  • At least 5 – 10 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.