BD (Becton, Dickinson and Company) Director, Regulatory Affairs in San Diego, California
Job Description SummaryThis position is responsible for the global activities of the MMS Regulatory Affairs department according to BD corporate procedures. The incumbent is responsible for developing and following a strategy ensuring regulatory compliance.
Essential Duties & Responsibilities:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the responsibilities of the position.
Coordinates the global activities of the entire Medication Management Solutions (MMS) Regulatory Affairs (RA) staff.
Works with MMS management as required to establish and periodically measure RA department goals and objectives which are consistent with overall Divisional and Corporate Driver Goals.
Works with both domestic and international counterparts in the development of global regulatory strategies and plans.
Manages fiscal responsibilities for the RA department by planning and preparing an annual operating budget, and monitoring revenues and expenditures throughout the budget cycle.
Assesses priorities and makes assignments to team members to assure project and company priorities are met.
Is familiar and complies with corporate and divisional procedures and policies, and government regulations, as they pertain to MMS products.
Keeps abreast of new methods and developments in the regulatory field and effects appropriate modifications to division activities.
Provides timely information to divisional management on issues which will impact business performance.
Assures that U.S. and International submission activities are completed in an organized and timely manner.
Provides oversight and prepares new product submissions as required, directs preparation of International, FDA and other required MMS business and BD corporate reports, and ensures RA department support on new product teams.
Presents RA department issues, progress reports, etc. to both divisional and corporate management, as required.
Develops department personnel for future assignment within the company.
Directs ongoing CE Marking activities, including required technical file/dossier updates, and compliance with EU MDR requirements.
Interacts with regulatory agencies to ensure a smooth working relationship.
Leads and/or supports FDA, Notified Body, and other audits/inspections.
Knowledge & Skills:
Ability to concurrently handle a variety of projects and coordinate the efforts of cross-functional team members.
Ability to analyze and use technical data and resources.
Ability to communicate with all levels of technical and operation management.
Strong understanding of medical, clinical, and regulatory issues related to device requirements.
Strong project management skills.
Strong leadership and decision making skills.
Strong negotiation skills.
Strong motivational skills.
Excellent verbal and written communication skills.
This position is in an office environment and requires the incumbent to perform general office functions.
This position requires:
Bachelor's Degree in Life or Engineering Science.
Ten years of progressively more responsibilities as a multi-functional Regulatory Affairs professional or equivalency.
Experience in International Regulatory Affairs, CE Marking, EU MDR requirements, and U.S. Regulatory Affairs decision making.
Project management experience, knowledge of product development and the QSRs for medical devices.
Knowledge and experience working with regulatory requirements for infusion pumps.
Demonstrated communication and human relation skills.
Regulatory Affairs Certification.
Experience working in a cross-functional team environment for new product development.
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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