Additional Locations: Purpose and Passion - Comprehensive Benefits - Life:Work Integration - Community - Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the Role:
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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.
Your Responsibilities Include:
:Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
:Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
:Establish regulatory reportability decisions using event investigation and regulatory decision models.
:Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government:mandated regulations.
:Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmition 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.
:Compose 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.
:Assist in the receipt and processing of returned devices.Assist with engineering evaluations.
:Assist with generation and updates of procedures (engineering changes).Give monthly updates of complaints as required per procedures.
:Be in compliance with Feeder System responsibilities as the Complaint Feeder System owner. Perform additional duties as assigned. Become a trainer for the Software related with complaints handling process (GCS2), as required.
:Responsible to be the complaint Subject Matter Expert ( SME) ready to be audited at any time. Responsible to maintain the complaint department in compliance with all corporate and applicable regulations related to complaint investigation site.
:Assist Quality Systems group on training activities as required. Act as supervisor of the Complaints Inspector if required. May act as the Complaints Area Coordinator, as required. If assigned, could be required to perform activities such as:Assign complaints to other Engineers or Inspectors in the area for its analysis and investigation as required Review and approve Complaints Investigations as required. Evaluate the investigation findings as documented in the investigation record. Determine at this time if all investigation requirements have been completed. Send the record back to the investigator for rework or approve the record Coordinate area projects as applicable.
What Were Looking For:
:Bachelors degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Enginnering or related Field.
:English Leve
