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Head of Regulatory Compliance

2 months ago

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

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

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 in alignment with FDA and state regulations, AATB Standards, and other relevant guidelines.

Key Responsibilities:

  • Develop and execute regulatory strategies to ensure compliance 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 and foster effective relationships with regulatory bodies.
  • Oversee the supplier management program.
  • Review marketing and sales promotional materials for regulatory compliance.
  • Manage the regulatory review and approval process for deviations, nonconformances, complaints, and corrective actions.
  • Draft and update procedures in accordance with FDA, AATB, and other applicable regulations.
  • Oversee the submission management of FDA/AATB reportable events.
  • Direct the management of state license applications and renewals.
  • Supervise the submission and renewal processes for unique device identifiers (UDI).
  • 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.
  • Monitor regulatory updates and conduct internal compliance evaluations.
  • Keep abreast of FDA activities, including enforcement actions and warning letters, to assess their impact on the organization.
  • Collaborate with Product Development & Management to support project timelines.
  • Provide regulatory guidance and approval for new initiatives and products.
  • Encourage shared leadership and collaboration across multidisciplinary teams.
  • Maintain knowledge of FDA regulations, AATB standards, and other relevant policies.
  • Ensure proper documentation and record-keeping in accordance with standard operating procedures.
  • Manage and mentor direct reports.
  • Set and evaluate annual 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.
  • Perform additional related duties as required.

Required Skills and Qualifications:

  • In-depth knowledge of relevant government regulations.
  • Ability to educate department leaders on compliance-related regulations and policies.
  • Exceptional attention to detail and organizational capabilities.
  • Proficient in multitasking.
  • Strong verbal and written communication skills.
  • Demonstrated leadership abilities.
  • Capacity to maintain a favorable background investigation and clearance.

Education and 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.