Staff Specialist, Post Market Quality

Regulatory Jobs; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD is seeking a Staff Specialist, Post Market Quality (PMQ) to serve as a global SME supporting post-market quality activities across the MMS portfolio. The role partners with the Senior Manager, PMQ to drive field actions, surveillance, risk management, and regulatory compliance.

The ideal candidate will have strong expertise in medical device quality systems and regulatory requirements, with the ability to influence decisions and align global stakeholders across Quality, Regulatory Affairs,

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or related technical field.
• Minimum 5 years of experience in Quality, Regulatory Affairs, Post Market Quality, Product Quality, or related functions within a regulated industry.
• Experience supporting post-market quality activities, quality investigations, risk management, or field actions.
• Strong analytical, problem-solving, and decision-making skills.
• Demonstrated ability to influence cross-functional stakeholders and drive organizational alignment.

Responsibilities

• Lead and support the execution of global field actions, including recalls, corrections, removals, advisory notices, and other post-market actions.
• Develop and maintain field action documentation, rationale packages, health hazard evaluations, effectiveness strategies, and closure documentation.
• Partner with regional quality and regulatory teams to support consistent field action implementation across NA, EMEA, LATAM, and Greater Asia.
• Monitor field action progress, effectiveness, reconciliations, and closure activities to ensure compliance.
• Support regulatory submissions and notifications including FDA 806 reporting and global field action reporting requirements.

Skills

Quality systems

Regulatory compliance

Risk management

Cross-functional influence

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs

Job description

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

The Staff Specialist, Post Market Quality (PMQ) serves as a global subject matter expert supporting post-market quality activities across the Medication Management Solutions (MMS) portfolio. This role partners closely with the Senior Manager, PMQ, to drive the execution and continuous improvement of global field actions, post-market surveillance, risk management, quality system integration, and regulatory compliance activities.

The Staff Specialist provides technical leadership and strategic support for recalls, corrections, removals, advisory notices, complaint trending, CAPA integration, and regulatory reporting. This position collaborates across Quality, Regulatory Affairs, Medical Affairs, Engineering, Operations, and regional teams to ensure timely, compliant, and effective management of post-market quality activities.

The ideal candidate possesses strong expertise in medical device quality systems, regulatory requirements, risk management, and post-market surveillance, with the ability to influence decisions and drive alignment across global stakeholders.

Key Responsibilities

Global Field Action Execution & Support

• Lead and support the execution of global field actions, including recalls, corrections, removals, advisory notices, and other post-market actions.
• Develop and maintain field action documentation, rationale packages, health hazard evaluations, effectiveness strategies, and closure documentation.
• Partner with regional quality and regulatory teams to support consistent field action implementation across North America, EMEA, LATAM, and Greater Asia.
• Monitor field action progress, effectiveness, reconciliations, and closure activities to ensure compliance with internal and external requirements.
• Support preparation of materials for Field Action Committee (FAC) reviews and decision-making.

Risk Assessment & Quality Decision Support

• Support development of defensible quality and regulatory decisions through clear documentation and risk justification.
• Identify emerging trends and product performance concerns that may require corrective or preventive action.
• Provide technical expertise during investigations involving product quality, safety, reliability, and compliance issues.

Regulatory Compliance & Audit Support

• Support regulatory submissions and notifications including FDA 806 reporting and global field action reporting requirements.
• Prepare and review documentation supporting regulatory agency interactions, audits, inspections, and inquiries.
• Ensure post-market quality activities meet applicable regulatory requirements and company procedures.
• Contribute to inspection readiness activities through strong documentation practices and quality system compliance.

Analytics, Metrics & Reporting

• Develop and maintain key performance indicators (KPIs) and dashboards related to post-market quality and field actions.
• Analyze effectiveness trends, risk signals, reconciliation data, closure performance, and recurring quality issues.
• Generate executive-level reports and summaries to support leadership decision-making.
• Identify opportunities to strengthen data visibility and proactive quality management.

Cross-Functional & Global Collaboration

• Collaborate with stakeholders across Quality, Regulatory Affairs, Engineering, Operations, Supply Chain, Medical Affairs, and Commercial teams.
• Provide technical leadership through influence and expertise to achieve alignment on quality and compliance strategies.
• Support global consistency in post-market quality processes and execution standards.
• Serve as a trusted advisor and resource for post-market quality and field action-related matters.

Continuous Improvement & Change Leadership

• Drive process improvement initiatives that enhance efficiency, compliance, and effectiveness of post-market quality systems.
• Participate in quality transformation efforts, Kaizen activities, and operational excellence programs.
• Recommend process enhancements based on lessons learned, regulatory expectations, and industry best practices.
• Foster a culture of proactive risk identification and continuous improvement.

Qualifications

Required

• Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or related technical field.
• Minimum 5 years of experience in Quality, Regulatory Affairs, Post Market Quality, Product Quality, or related functions within a regulated industry.
• Experience supporting post-market quality activities, quality investigations, risk management, or field actions.
• Strong analytical, problem-solving, and decision-making skills.
• Demonstrated ability to influence cross-functional stakeholders and drive organizational alignment.

Preferred

• Medical device industry experience.
• Knowledge of global field action and post-market surveillance requirements.
• Experience with complaint handling, CAPA, risk management, and quality system processes.
• Experience supporting regulatory inspections and audit readiness activities.
• Advanced data analytics and KPI development experience.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$129,600.00 - $207,400.00 USD Annual