Head of Regulatory Compliance

1 week ago

San Antonio, Texas, United States Extremity Care Full time
Position Overview

Salary: $116,288.

Objective:

The Head of Regulatory Compliance is tasked with managing all aspects of regulatory affairs, ensuring adherence to the regulatory framework, submissions, and operational functions. This role is critical in maintaining compliance with FDA regulations, state mandates, AATB Standards, ISO Standards, and other relevant international requirements.

Key Responsibilities:

  • Develop and execute regulatory strategies to ensure alignment with FDA and state regulations, AATB Standards, and other pertinent guidelines.
  • Contribute to the achievement of organizational strategic goals.
  • Facilitate external audits and collaborate with Quality Assurance to generate responses and corrective action plans.
  • Act as the primary regulatory liaison with governmental bodies, fostering effective relationships with regulatory agencies.
  • Oversee the regulatory review of procedures, marketing materials, and promotional content.
  • Manage the regulatory review and closure of deviations, nonconformances, complaints, and corrective actions.
  • Draft and update procedures in compliance with FDA, AATB, and other relevant regulations.
  • Supervise the management and submission of FDA/AATB reportable events.
  • Direct the submission and renewal processes for state licenses.
  • Oversee unique device identifier (UDI) submissions and renewals.
  • Manage regulatory submissions for TRG letters, Requests for Designation (RFD), premarket notifications, and 510(k) applications.
  • Lead the development and maintenance of design control and risk management procedures.
  • Guide the regulatory pathways for new product development, identifying appropriate FDA product codes and regulatory requirements.
  • Support the creation of qualification and validation protocols, ensuring compliance with regulatory standards.
  • Conduct regulatory reviews of validation plans, protocols, and execution data.
  • Provide regulatory guidance for clinical studies and research manuscripts.
  • Establish a monitoring program for regulatory updates and internal compliance assessments.
  • Analyze FDA activities, including enforcement actions, to assess company impact.
  • Collaborate with Product Development to support project timelines.
  • Provide regulatory oversight for new initiatives and products.
  • Encourage collaboration across multidisciplinary teams for project success.
  • Maintain knowledge of FDA regulations, AATB standards, and relevant policies.
  • Ensure proper documentation and record-keeping in accordance with standard operating procedures.
  • Manage and mentor direct reports, establishing annual goals and conducting performance evaluations.
  • Recruit and select qualified personnel for the team.
  • Travel as necessary to attend meetings and conferences.
  • Participate in scheduled meetings and complete assigned responsibilities.
  • Perform additional duties as required.

Qualifications:

  • Bachelor's degree in biological sciences or a related field is required.
  • A Master's degree is preferred.
  • 5 to 10 years of experience in quality and/or regulatory affairs within an FDA-regulated environment, with progressive management responsibilities.

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