BD (Becton, Dickinson and Company) Sr. Director Regulatory Compliance - Remote in Franklin Lakes, New Jersey
Job Description Summary
POSITION TITLE : Sr. Director Regulatory Compliance
DEPARTMENT : Regulatory Affairs
REPORTS TO : Chief Regulatory Officer
Becton, Dickinson, and Company (BD) recently announced its intention to spin-off the Diabetes Care business unit into a separate public company. The Diabetes Care business of BD is the industry pioneer and leader in diabetes injection devices. The Diabetes Care business unit has a long history within BD and is unique in that it focuses on one significant disease state which is a threat to world health. BD Diabetes Care has an unequalled reach and connection to diabetic patients and has well-established relationships with key diabetes stakeholders and influencers worldwide. BD Diabetes Care has leveraged deep expertise and advanced technologies to continuously innovate their portfolio specifically tailored to the needs of Type II diabetics. Their products are diligently designed to enable people who are living with diabetes to do so with comfortable, effective care.
It is contemplated that within the coming months, BD will spin off Diabetes Care into a new publicly owned corporation, which will be named embecta (“NewCo”).
The statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified.
JOB SUMMARY :
The Sr. Director Regulatory Compliance is responsible for working with all designated sites worldwide on various regulatory compliance issues such as WW vigilance reports and field actions, as well as working across the business leading major projects and initiatives. This position reports directly to the Chief Regulatory Officer.
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 embecta.
DUTIES AND RESPONSIBILITIES :
Regulatory Compliance activities, including:
Develop and maintain the processes and supporting procedures for regulatory compliance activities including but not limited to WW adverse event reporting, field action execution, and other WW compliance reporting required by regulatory authorities, to ensure consistency of information and a “one voice” approach to WW regulators.
Provide regulatory compliance assessment as part of the due diligence assessment for acquisitions
Develops and maintains WW compliance metrics, and, in conjunction with Quality Management, uses these metrics to improve processes, efficiency, and the quality of products and systems.
Oversees all recall or other compliance related customer notification activities including reports of such actions to regulators. Ensures timely decision-making and actions. The responsibility for the execution of such compliance actions may be delegated to Regulatory Compliance Managers within the regions and/or outsourced agency.
Facilitates the Field Action process for embecta to assure product quality issues that may result in a field action are appropriately assessed, documented, and approved in collaboration with Quality, Regulatory Affairs, and Medical Affairs leadership.
Collaborates on the development of the Situation Analysis (SA) and Health Risk Assessment (HRA), as required. SAs and HRAs 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/or executes Product Recalls and Field Safety Corrective Action Notices with Customers, Dealers, and regional regulatory representatives.
Facilitates communication with the region and all regulatory bodies WW regarding field actions, as needed.
In conjunction with Quality Management, participates in management reviews of the Quality System. Assures management is adequately informed of opportunities for improvement and helps develop strategic and tactical plans for same, including the identification of resource requirements to accomplish tasks within appropriate time periods.
Works closely with the Complaint Management Centers to assure embecta remains compliant with US and other International Adverse Event Reporting activities.
Oversees the submission of MDR and WW vigilance reporting to include any agencies providing outsourced reporting services.
Responds to and maintains communications with the FDA on MDR trends, FDA Inspections, 483 Responses, Additional Information Requests, and other communication topics, as needed.
Actively participates in FDA Inspections; both pre-inspection activities, inspection management, and 483 Responses.
Provides support service for embecta legal in response to litigation as requested
Serves as a strategic partner to various regional leadership on matters of WW regulatory compliance, consistency of dissemination of information across sites/regions, and future development opportunities.
Works embecta Quality and Regulatory Affairs teams to define and manage policies and procedures for the WW businesses relative to adverse event reports, the management of product recalls and notifications, and responses to inquiries by regulators or other governmental bodies.
In conjunction with Regulatory Affairs, collects information on new and evolving regulations, guidances, and policies associated with FDA, other US government Agencies regulating health care products and international regulatory agencies or their equivalents. Analyzes and disseminates this information and provides training on those issues relevant to embecta.
Manages compliance staff for assigned business responsibilities.
B.A. or B.S. in the life sciences or engineering; Advanced degree desirable
Experience in the medical device, pharmaceutical or biologics industries with specific experience in post market quality, regulatory compliance, quality systems, audits / inspections, and adverse event reporting
Strong experience in US and EU regulatory systems and practices
Knowledge of fraud and abuse regulations
Experience in coaching, development, and management of staff
Excellent verbal and written communications skills
Ability to work in a team environment
For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Primary Work Location
USA NJ - Franklin Lakes
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, or any other protected status.