Product Analyst I

Product Analyst I

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Your responsibilities will include :

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

Required qualifications :

Preferred qualifications :