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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