Regulatory Specialist Job at ACE Partners, Charlotte, NC

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  • ACE Partners
  • Charlotte, NC

Job Description

Job Title: Regulatory Specialist

Overview:

This role is responsible for ensuring regulatory compliance by managing recalls, medical device reports (MDRs/MPRs), and critical complaints. The Specialist will lead regulatory submissions, liaise with authorities, and support corrective actions in alignment with FDA, ISO, and other global standards.

Key Responsibilities:

  • Develop and maintain procedures for recalls, MDR/MPR, and complaint handling.
  • Lead the preparation and submission of MDRs, MPRs, recalls, and FSCAs.
  • Serve as the SME during regulatory audits and inspections.
  • Maintain effective communication with internal teams and external stakeholders.
  • Ensure accurate and timely regulatory submissions and documentation.
  • Prepare and coordinate customer notifications and field corrections.
  • Collaborate with global regulatory teams and support regulatory authority interactions (FDA, Health Canada, etc.).
  • Oversee corrections, removals, and recalls.
  • Drive investigations and trend analysis for critical complaints.
  • Generate statistical reports to identify systemic issues.

Qualifications:

  • 5–8 years of experience in the life sciences industry, preferably medical devices.
  • Bachelor’s degree in a scientific or healthcare-related field (preferred).
  • Demonstrated expertise in medical device recalls, MDRs, and complaint handling.
  • Strong regulatory writing and submission experience.
  • Familiarity with FDA regulations (21 CFR 803, 806, 820, 830) and ISO 13485/14971.
  • Experience with FDA eSubmitter and ESG platforms.
  • Solid understanding of Quality Management Systems in regulated environments.

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