Job Description Summary

Manager, Regulatory Affairs will represent Regulatory Affairs within WW Infusion Specialty Disposables (WWISD) platform of the Medication Delivery Solutions business unit of Becton Dickinson (BD) on new product development, product engineering, and other product development initiatives and maintenance activities.
This position focuses on the implementation of Regulatory Affairs (RA) procedures, processes related to multiple projects. Responsible for creating and executing regulatory strategies and objectives for pre-market programs in alignment with business needs. These regulatory strategies may influence the scientific or technical direction of product design and/or development. The Manager, Regulatory Affairs is responsible for mentoring RA associates, for ensuring functional excellence, and for establishing collaborative relationships with other functional leaders.

Job Description

Manager, Regulatory Affairs  

The Manager,  Regulatory Affairs will represent Regulatory Affairs within WW Infusion Specialty Disposables (WWISD) platform of the Medication Delivery Solutions business unit of Becton Dickinson (BD) on new product development, product engineering, and other product development initiatives and maintenance activities.

This position focuses on the implementation of Regulatory Affairs (RA) procedures, processes related to multiple projects. Responsible for creating and executing regulatory strategies and objectives for pre-market programs in alignment with business needs.  These regulatory strategies may influence the scientific or technical direction of product design and/or development.  The Associate Director Regulatory Affairs is responsible for managing RA associates, for ensuring functional excellence, and for establishing collaborative relationships with other functional leaders.

RESPONSIBILITIES

• Provides regulatory leadership for programs in the pre-market space for the WWISD Regulatory Team
• Works with Associate Director and Director of Regulatory Affairs and LT members to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans
• Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other regulatory bodies for WWISD products
• Prepares, or directs the preparation of global regulatory submissions.
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders
• Monitors Worldwide regulatory developments affecting the Business Group’s Platforms and Programs and communicates emerging opportunities and concerns to stakeholders
• Represents WWISD in interactions/negotiations with global U.S. regulatory agencies enables /empowers staff to interact and negotiate with regulators
• Mentors  staff of regulatory professionals carrying out product submission/registration activities.  Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives
• Conducts training on regulatory issues for staff and for business stakeholders (e.g., Clinical, R&D., Marketing)
• Reviews and approves labels, labeling, promotional materials, clinical protocols, and clinical reports
• Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
• Reviews labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc.
• Provides regulatory review and approval for product marketing communications.

REQUIREMENTS

• B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry).  Advanced degree preferred.
• Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device
• Working knowledge of regulations for infusion pump sets, gravity IV sets and associated devices.
• Understanding of regulations for sterile disposable products. 
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Experience in negotiating with FDA personnel in CDRH .

  Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (510(k), IDE) to FDA and other regulatory agencies.

• Demonstrated leadership skills.
• Demonstrated project management, negotiation, and communication (written and oral) skills.
• Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
• Comprehensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.
• RAPS Certification preferred

SPECIFIC SKILLS & ABILITIES:

• Ability to read, analyze, and interpret regulatory literature and documents.
• Ability to format regulatory submissions that conform to prescribed style and format.
• Ability to effectively communicate information to peers and management. Ability to translate regulations and guidelines into terms that other functions can understand.
• Ability to define problems, collect data, establish facts, and draw valid conclusions, and then communicate the information both verbally and in writing to a variety of audiences.
• Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
• Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.
• Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
• Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
• Experienced in meeting with, making presentations to, and negotiating with leadership and/or regulators.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift