Regulatory Specialist

Summary:

Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.

Project Details:

• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations
• Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis
• Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models
• Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff
• Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers. Communications include determination/eligibility for warranty credit or unreimbursed medical payments

Job Experience:

• Prior experience within complaint or regulatory handling
• Experience in medical device or healthcare industry – clinical knowledge is preferred

Language Required: English