Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

This role will lead the Product Quality and Communications (PQC) team, which is responsible for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the FDA and other regulatory agencies (e.g., recall letters) are implemented at the business unit; these may include improvements to processes or products; and 3) approach and processes for CAPA initiation determination, Situation Analyses and escalation to Field Action Committee decisions are consistently applied across the MMS BU.  This team will bring strong quality systems, technical, and project management experience to be able to align information from cross-functional areas within the business unit with expectations from external regulatory contacts.  Activities include:

• Facilitates the collection of information and technical writing of communications with FDA and other regulatory agencies, including periodic reports for responses to audits and inspections, enhanced post-market surveillance reports, field remediation reports, “Additional Information Requests” related to inquiries about adverse events, device malfunctions, or recalls, and other communications

• Facilitates the implementation of commitments made to FDA and other regulatory agencies, including end-to-end process improvements, procedural updates, design/manufacturing/labeling changes, etc.

• Coordinates and facilitates a unified approach and process for CAPA initiation determination processes leading to the creation of CAPAs, product investigations (SAs) and escalation to Field Action decision, as applicable.

• Collaborates with leadership in Business Unit Quality, Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional Compliance, and Post Market Quality on the review and approval of the communications

• Actively participates in inspections and audits at the San Diego, Tijuana, and other sites as required, including pre-inspection activities, inspection management, responses, and remediation

• Actively participates in workshops for process or product improvements at the San Diego, Tijuana, and other sites as required

• Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business unit projects and reports to meet established goals

Minimum Qualifications:

• Bachelor's degree Engineering or other technical field

• Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III devices, or Pharmaceuticals

• Minimum 5 years of direct management experience

• Expert knowledge of 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, ISO 13485, ISO 14971, and other international standards, as required

• Expert knowledge of design controls and risk management

• Experience in front room and support room during internal and external audits

• Experience in navigating complex regulatory and product certification landscapes

• Knowledge and experience in making field action and non-field action decisions

• System-level thinking: ability to design, develop, and maintain complex systems, focusing on the overall architecture and functionality rather than individual components

• Critical thinking: problem identification, analysis, and formulation of conceptual / technical and business solutions

• Continuous improvement and influence: Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence

• Excellent written and oral communication skills; demonstrated through provided examples of appropriate written communication where possible

• Excellent strategic planning and prioritization skil