Quality Systems & Regulatory Lead; Post Market

Job Description Summary

Job Description Summary The Quality Systems and Regulatory Staff Lead ensure robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups. This role evaluates quality signals to determine escalation, aligns investigations and corrective actions with regulatory requirements, and partners cross-functionally to scope field actions, collaborates and provides feedback on the Post Market Risk Assessment and Health Hazard Evaluation (HHE) process and facilitates its completion, and delivers data-driven insights for decision-making.

Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and leverages analytics to monitor KPIs, identify systemic issues, and implement timely, validated solutions that uphold product safety, compliance, and customer trust.

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• Support the development, execution, and governance of remediation and prevention strategies as well as post market issue impact/risk assessments. Ensure alignment with regulatory requirements and internal quality standards.
• Evaluate potential issues before formal CAPA initiation. Conduct structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted. Ensure that issues are appropriately prioritized, risk-ranked, and moved forward based on impact and recurrence. Partner with multiple functional areas to gather relevant data and context, enabling informed decisions and timely initiation of CAPA when necessary.
• Confirm that CAPA investigations are directly tied to the reason for the recall. Ensure that corrective and preventive actions are appropriate, mitigations are suitable, and implementation plans are robust. Verification of effectiveness (VOE) plans must be clearly defined, thoroughly tested, and documented to demonstrate sustained resolution of the issue.
• Support comprehensive issue impact and risk evaluations (SAs). Help teams apply a risk-based method to prioritize process and product issues, actions, and partner concerns for the field action committee. Facilitate discussions with medical affairs and other relevant function to understand issue's impacts on patients, business operations, and regulatory compliance, quantify risk levels, and deliver actionable recommendations that enable informed decision-making and proactive mitigation strategies.
• Ensure HRA or HHE alignment by collaborating with cross-functional teams to determine the scope of field actions. Facilitate HRAs or Health Hazard Evaluations (HHEs) to assess clinical risk and support decision-making.
• Partner with cross functional teams to help them develop and deliver clear, data-driven presentations to the committee deciding the field actions. Support alignment on issue impact assessments/risk assessment, scope definition, and mitigation strategies for recalls and related actions, enabling informed and collaborative decision making.
• Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure timely and accurate updates on mitigation activities.
• Drive End-to-End Process Improvements Throughout the Quality System:
  Identify inefficiencies and gaps across the quality lifecycle. Lead initiatives to streamline processes, enhance compliance, and improve overall system…