Regulatory Specialist
Monroe, US, 28110
Your challenge
• Establish and maintain procedures for recalls, medical device reporting (MDR/MPR), and critical complaint handling.
• Lead, manage, and prepare submissions for MDRs, MPRs, recalls, and Field Safety Correction Reports (FSCA).
• Serve as the subject matter expert (SME) during regulatory inspections and audits.
• Develop and maintain strong relationships with internal teams, external stakeholders, and key opinion leaders (KOLs).
• Ensure timely and accurate submissions to regulatory authorities.
• Prepare customer notifications, communications, and documentation related to field corrections. Maintain essential records for regulatory complaince.
• Coordinate customer communication mailings using internal and third-party resources.
• Collaborate with GBO sites and regulatory professionals per company procedures.
• Interface directly with the FDA, Health Canada and other regulatory bodies on recalls, MDRs, MPRs, and vigilance reporting.
• Manage mandatory corrections, removals, and recalls efficiently and effectively.
• Drive investigations and responses for critical complaints with cross-functional teams.
• Perform statistical evaluations and prepare trending reports and summaries to identify potential systemic issues.
• Perform additional duties as assigned.
Your Profile
• 5-8 years of experience in the life sciences industry, preferably in medical devices.
• Bachelor’s degree in a scientific or healthcare-related field (preferred).
• Proven experience in executing medical device recalls, MDR submissions, and critical complaint handling.
• Strong technical writing skills for regulatory or government submissions.
• In-depth knowledge of FDA regulations (21 CFR Parts 803, 806, 820, 830) and ISO standards (13485, 14971).
• Demonstrated ability to interact with regulatory authorities (FDA, Health Canada, etc.) via written and in-person communications.
• Hands-on experience with FDA eSubmitter and FDA ESG systems.
Our Offer
Nearest Major Market: Charlotte