Head of Regulatory Compliance

1 week ago

Conshohocken, Pennsylvania, United States Extremity Care Full time
Job Overview

Salary Range: $116,288 - $174,432

Role Purpose:

The Head of Regulatory Compliance is tasked with managing all aspects of regulatory affairs, ensuring adherence to the regulatory framework, submissions, and operational functions to maintain compliance with FDA and state regulations, AATB Standards, and other relevant guidelines.

Key Responsibilities:

  • Develop and execute regulatory strategies to ensure alignment with FDA and state regulations, AATB Standards, and other relevant guidelines.
  • Support the organization’s strategic goals.
  • Lead and manage the internal audit program.
  • Coordinate external audits and work with Quality Assurance Management to formulate audit responses and corrective action plans.
  • Act as the primary regulatory liaison, fostering effective relationships with regulatory bodies.
  • Oversee the supplier management program.
  • Review and approve regulatory aspects of procedures, marketing, and promotional materials.
  • Manage the regulatory review and closure of deviations, nonconformances, complaints, and corrective actions.
  • Draft and update procedures in compliance with FDA, AATB, and other regulations.
  • Oversee the management of submissions for FDA/AATB reportable events.
  • Direct the management of state license applications and renewals.
  • Supervise unique device identifier (UDI) submissions and renewals.
  • Manage regulatory submissions for TRG letters, Requests for Designation (RFD), premarket notifications/approvals, and 510K submissions.
  • Assist in the development of qualification and validation protocols to ensure regulatory compliance.
  • Review and approve validation plans, protocols, and execution data to confirm adherence to regulatory standards.
  • Implement a monitoring program for regulatory updates and internal compliance assessments.
  • Keep abreast of FDA activities, including enforcement actions and warning letters, to evaluate their impact on the organization.
  • Collaborate with Product Development & Management to establish and support project timelines.
  • Provide regulatory guidance and approval for new initiatives and products.
  • Encourage shared leadership and collaboration across multidisciplinary teams.
  • Maintain up-to-date knowledge of FDA regulations, AATB standards, and other relevant policies.
  • Ensure proper filing and maintenance of records in accordance with standard operating procedures.
  • Manage and mentor direct reports.
  • Set and monitor annual performance objectives for team members.
  • Conduct performance evaluations and implement improvement plans as necessary.
  • Participate in recruitment and selection processes for new hires.
  • Engage in offsite business meetings and conferences.
  • Fulfill other related duties as assigned.

Qualifications:

  • Extensive knowledge of relevant government regulations.
  • Ability to educate and inform department leaders on compliance requirements.
  • Strong attention to detail and organizational capabilities.
  • Proficient in multitasking.
  • Excellent verbal and written communication skills.
  • Demonstrated leadership abilities.
  • Capability to secure and maintain a favorable background check and clearance.

Education & Experience:

  • 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 for HCT/Ps and/or medical devices, with progressive management responsibilities.

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