BD (Becton, Dickinson and Company) Sr. Manager, Regulatory Compliance in Franklin Lakes, New Jersey
Job Description SummaryThe Sr. Regulatory Compliance Manager is responsible for working with all designated sites worldwide on various regulatory compliance issues as well as working across the business leading major projects and initiatives. This position reports directly to the Sr. Director, Regulatory Compliance.
The position is accountable for the development and execution of strategies and plans to meet key operational goals. Assumes critical leadership role in key projects. Erroneous decisions could result in significant regulatory risk and regulatory action taken against BD.
DUTIES AND RESPONSIBILITIES :
Regulatory Compliance activities, including:
Manages the Field Action process for designated business units to assure BD addresses product quality issues that may result in a field action.
Collaborates on the development of the Situation Analysis (SA) and Health Hazard Evaluation(HHE), as required. 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.
Collaborates with leadership in Quality and Medical Affairs on the development and approval of the Field Action decision.
Manages and/or executes Product Recalls and Field Safety Corrective Action Notices with Customers, Dealers, and regional regulatory representatives.
Communicates with the FDA regarding field actions, as needed.
Oversees Medical Device Reporting process and procedures.
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.
Assists standards management activities for product standards which impact BD, as needed.
Provides support service for Becton Dickinson legal in response to litigation as requested
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA MD - Baltimore
Work Shift830am-5pm FLakes Core Hours (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status