We are the people who give possibilities purpose

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.

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. 

The Sr. Manager, Post Market Quality, MMS is based in North America and reports to the Director, MMS Product Quality & Communications  . The job holder is accountable for the end-to-end field action process for the MMS business unit, including,

• Timely execution of field actions within North America while aligning and coordinating with Regional PMQ Representatives from EMEA, LATAM and Greater Asia to ensure alignment of field action execution.

• Conducting timely Field Action Committee (FAC) meetings.

•  Providing customer and regulator input into FAC decisions.

• Ensuring FAC decisions are consistent and align with regulator expectations.

• Ensuring field action documentation (customer letter, 806 report, GRIA, etc.) is created.

• Monitoring field action reconciliation and guiding the PMQ Field Action Operations organization to ensure appropriate effectiveness levels are achieved based on the Field Action Strategy.

• Ensuring alignment between field actions, CAPAs, complaint trends, and post‑market surveillance activities to support sustainable risk reduction

• Driving global alignment on field action strategy, timelines, and execution expectations in partnership with regional PMQ representatives

• Use of metrics and data analytics to assess field action execution, effectiveness, and emerging post‑market risks.

  • Coordination with regulatory bodies (FDA, etc.) as needed

• Audit Support for field actions and related decisions

• Continuous improvement projects as needed

Qualifications:

• BA/BS degree or equivalent in a Life Science, Engineering, Physical Science, Nursing with an advanced technical degree; MBA preferred

• Minimum of 10 years of experience in quality & regulatory management within an FDA/Competent Authority regulated environment.

• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device and / or in vitro diagnostics industries, e.g., 21 CFR Parts 7, 806, ISO 13485, 14971 etc.

• Strong preference for FDA Class II and Class III medical device and / or in vitro diagnostics experience, and prior BD experience is highly desirable.

• Excellent written and oral communication and organizational, project management skills.

• Ability to continuously assess the effectiveness of functional processes and to lead progres