Post-Market Compliance Specialist III- Autoimmunity

Overview

Job Summary

The Post-Market Compliance Specialist III supports product complaint management as well as post-market surveillance and reporting for in-vitro diagnostic (IVD) products. Responsibilities include complaint intake for complex issues, regulatory reportability, technical investigation, laboratory testing, issue risk assessment, documentation and communication with customers and Affiliates for IVD assays and systems. The position is responsible for Post-Market Surveillance, Device Reporting, and Field Action activities.

The role collaborates with other internal teams and global affiliates and contributes to process improvements. The role provides subject matter expertise in technical and customer relationship management to junior members of the team.

Key Accountabilities

• Complaint Management:
  Intakes, assesses for regulatory reportability, and triages assigned complaints. Designs and executes complex experiments and performs complex complaint investigations including investigation approach determination, experimental design, testing, analyses, and resolution. Triages investigations to other internal departments or manufacturers as needed and follows up with the escalated parties until complaint resolution. Communicates throughout the complaint investigation process from intake to final resolution with customers, affiliates, and internal stakeholders.
  
  Presents product issues which should potentially be brought to the Quality Review Board or Field Action Board to PMC management. Prepares presentations and presents issues to QRB and FARB.
• Laboratory Organization:
  Maintains laboratory cleanliness and organization. Performs routine cleaning and complete required documentation. Monitors and maintains inventory levels of laboratory test samples, consumables, reagents, and other materials. Ensures laboratory equipment and tools equipment maintenance, calibration, service, and software versions are current.
• Tracking and Trending:
  Conducts complaint trend analyses and coordinates the preparation of post-market surveillance (PMS) reports. Prepares Management Review slides on PMS for department management.
• Field Actions:
  Authors field action assessments and ensures completion of Health Hazard Evaluations (HHE/HHA) and leads recalls, Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs), and associated regulatory notifications.
• Reportable Events:
  Completes, files and follow ups on reportable events to regulatory authorities.
• Department Procedures:
  Assists in drafting, implementing, and maintaining departmental procedures, work instructions, and templates.
• Provides technical guidance and mentoring to junior staff. In consultation with department management, develops and executes training for new and developing staff.
• Complies with applicable standard operating procedures, applicable standards and regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Demonstrates Werfen values through the quality of work and professional working relationships.
• Other duties as assigned.

Networking/Key relationships

• Marketing and Global Systems Support teams
• Commercial teams
• Manufacturing teams
• Regulatory Affairs team
• R&D teams
• Werfen Affiliates
• Technical Support (MTS) team
• Werfen Affiliates

Minimum Knowledge & Experience required for the position:

Education and Knowledge:

• Bachelor’s degree in biological science, biochemistry, or similar field required. Master’s degree preferred.
• Proficient knowledge of IVD post-market quality system requirements and complaint handling.
• Advanced knowledge of global IVD post-market regulations and standards.
• Advanced knowledge with IVD reagents and diagnostic platforms, such as immunoassays, ELISA, chemiluminescent assays, and bead-based multiplex assays on automated systems.
• Advanced understanding of the functional and performance principles of IVD products, including reagents, calibrators, controls, software, and instrument systems.

Experience:

• Minimum of six (6) years of experience in IVD industry in complaint handling, regulatory function, or a closely related technical function,…