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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