DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies, and is recruiting for a Senior Manager Customer Quality Post-Market Regulatory located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Oversight of activities associated with global complaint handling, adverse event reporting, and Health Authority responses.
Lead Customer Quality associates responsible for Health Authority report submission and responses as well as associates responsible for Clinical assessments of complaints, Health Hazard Evaluations, and Preliminary Risk Assessment.
Develop, maintain and improve systems and processes associated with global Customer Quality activities.
• Lead a team of specialists and clinicians as part of a Customer Quality (Complaint Handling Unit).
• Responsible for compliance activities in accordance to the regulations and standards affecting Medical Devices (e.g. ISO 9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc.)), CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)).
• Oversee the timely filing of adverse events (i.e. MDR, MDV, MPR, etc.); manage processes and timelines associated with risk evaluations, QRB and CAPAs.
• Ensure that appropriate training and education plans are developed, implemented and maintained for personnel in accordance to divisional, corporate and regulatory guidelines.
• Continuously evaluate effectiveness of pertinent post market Quality Systems to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management.
• Serve as a subject matter expert for complex regulatory and compliance issues, including regulatory and procedural interpretations, processes such as risk assessment, investigation, medical device reporting and tracking/trending analysis during audits, inspections and assessments by regulatory agencies and corporate bodies.
• Work in partnership with Commercial Operation entities (Customer Service, R/D, Regulatory, Manufacturing, Legal, Quality, etc) in resolving customer issues and developing continuous process improvement initiatives.
• Actively participate in post market cross-functional team meetings, and present complex data to Executive staff members.
• Maintain, develop and implement processes for tracking, trending and analyzing post market data utilizing statistical tools and methodologies.