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Regulatory Compliance Manager
BD (Becton, Dickinson and Company)
Franklin Lakes, NJ US
Healthcare & Medical
Regulatory Compliance Manager
Title: Regulatory Compliance Manager Location: US-New Jersey-Franklin Lakes Job Number:_REG00063 Under the direction of the Segment Regulatory Compliance Director for the Medical Segment and PAS this Role: * Manages the Field Action Committee process across the Medical Surgical, Diabetes Care, and PreAnalytical Solutions to assure BD addresses product quality issues that may result in a field action * Manages compliance with good Situation Analysis (SA) practices and collaborates with Medical Affairs to provide Health Hazard Evaluations (HHE) where needed. These SA's and HHE's serve as the key inputs to the FAC process and are critical to making sound decisions relating to the quality issues and actions to be taken related to product in the field. * Manages and executes Product Recalls and Field Safety Corrective Action Notices with Customers, Dealers, and applicable Regulatory Agencies and communications with the FDA regarding * Oversees the Medical Device Reporting process and works closely with the Complaint Management Centers to assure BD remains compliant with US and other International Adverse Event Reporting activities * Responds to and maintains communications with the FDA on MDR trends, FDA Inspections, 483 Responses, and other communication topics as needed * Actively participates in FDA Inspections; both pre-inspection activities, inspection management, and BD 483 Responses * As needed coordinates standards management activities for those Product standards which impact BD
Required Skills and Knowledge * BS in Science/Engineering or Quality required * Certification in Regulatory Affairs/Compliance desirable * Working knowledge of 21 CFR820, 21 CFR210 and 211, 21 CFR806, ISO 13485, ISO 10011, and other international standards as required * Five plus years of Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices or diagnostics * Experience with sterile medical devices and/or diagnostics desirable * Capable of assisting in the development of regulatory compliance strategies * Experience product manufacturing and defect analysis desirable * Demonstrated ability to influence others (beyond direct reports) Technical Area of Expertise * Quality Engineering, Quality Auditing, Regulatory Compliance * Experienced working in and leading international cross-functional teams * Provides support service for Becton Dickinson legal in response to litigation as requested: 1) respond to product liability claims, 2) investigate/identify product hospital records and other discovery materials, 3) aid legal counsel as applicable, 4) Answer interrogatories and produce documents and other production, as required. Required: * Demonstrated ability to effectively handle multiple Project Priorities * Excellent Organization & Prioritization Skills * Demonstrated ability to Lead or share the leadership of Dynamic Work Teams * Excellent Communications Skills * Strong Project Management Skills * Excellent Facilitation Skills * Excellent Follow Up and Documentation Skills * Solid multi-directional Influence Management Skills * Developing Talent within Function
Preferred: * Experience working in Plant, Business Unit, or Regional Quality / Regulatory Roles * Solid knowledge of global regulatory and quality systems * Multilingual capability is a plus * Experience Managing Capital Projects (Financial Management)