Quality Systems & Regulatory Staff Lead

Becton Dickinson Medical Devices • San Diego, CA

14d • Onsite

About The Position

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 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.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 7 years of progressive experience in medical device Quality Assurance, with a proven track record of compliance excellence.
• Minimum 5 years of hands-on risk management expertise, including a deep understanding and practical application of ISO 14971 principles.
• Demonstrated experience in direct communication with FDA, including drafting and managing regulatory responses and correspondence.
• Comprehensive knowledge of global quality and regulatory standards, including ISO 13485, ISO 9001, 21 CFR Part 820, and EU MDR, with the ability to interpret and apply requirements effectively.
• Proven leadership capabilities, including driving cross-functional collaboration, influencing stakeholders, and leading complex quality initiatives.
• Strong analytical, problem-solving, and decision-making skills with the ability to manage multiple priorities

Responsibilities

• 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 performance. Support the successful execution of field corrective actions by ensuring solutions are readily available and thoroughly validated. Ensure solutions are accurately released and fully aligned with all applicable regulations and standards.
• Leverage data analytics to uncover opportunities for benchmark and KDG refinements by analyzing quality trends (15% of the time). Use advanced tools to monitor performance indicators, detect systemic issues, and propose targeted improvements. Lead weekly and daily management meetings with team members to evaluate metrics, foster accountability, and align on improvement strategies. Maintain continued transparency through multifaceted tracking and reporting of key performance measure

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees