Director, Field Assurance - Medical Devices

BD; Warwick (RI); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

BD is a global medical technology leader. The Associate Director, Field Assurance will lead complaint handling and regulatory reporting across the Surgery Business Unit, ensuring timeliness and compliance while monitoring product performance.

The role develops staff, drives continuous improvement, and collaborates with regulators as needed. A BS in engineering/science/biology/business and 5+ years in field complaints are expected.

Qualifications

• 5+ years related experience managing complaint handling in medical devices, pharma or biotech.
• Supervisory/management experience.
• Strong knowledge of medical device terminology and regulatory requirements.

Responsabilités

• Lead and supervise field complaint handling and medical device reporting across the Surgery Business Unit.
• Ensure timeliness, consistency and regulatory compliance with internal standards.
• Drive continuous improvement in complaint handling and regulatory reporting.
• Escalate significant events and trends to address quality and operations.
• Provide training, performance feedback and staff development.
• Present analysis of complaint handling and product performance in reviews.
• Support audit activities with SME expertise on complaints and regulatory reporting.
• Serve as liaison with regulatory agencies as needed.
• Maintain training, processes and systems to ensure compliance.
• Assist in budgeting for the area of responsibility.

Connaissances

Regulatory knowledge

Complaint handling

Leadership/management

Medical device terminology

Communication skills

Formation

B.S. degree in Engineering/Science/Biology/Business

Outils

Microsoft Office

Description du poste

BD is a global medical technology leader. The Associate Director, Field Assurance will lead complaint handling and regulatory reporting across the Surgery Business Unit, ensuring timeliness and compliance while monitoring product performance.

The role develops staff, drives continuous improvement, and collaborates with regulators as needed. A BS in engineering/science/biology/business and 5+ years in field complaints are expected.