BD (Tissuemed Ltd)
Quality Systems & Regulatory Staff Lead
BD (Tissuemed Ltd), San Diego, California, United States, 92189
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Job Description Summary The Quality Systems and Regulatory Staff Lead ensures 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. The Lead delivers data‑driven insights for decision‑making, 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.
Key Responsibilities
Support the development, execution, and governance of remediation and prevention strategies as well as post‑market issue impact/risk assessments, ensuring alignment with regulatory requirements and internal quality standards.
Evaluate potential issues before formal CAPA initiation through structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted, prioritizing and risk‑ranking issues based on impact and recurrence.
Confirm that CAPA investigations are directly tied to the reason for the recall and that corrective and preventive actions are appropriate, mitigating risks, with robust implementation plans and verification of effectiveness (VOE) plans.
Support comprehensive issue impact and risk evaluations (SAs) and apply a risk‑based method to prioritize issues for the field action committee, facilitating discussions with medical affairs and other relevant functions.
Ensure HRA or HHE alignment by collaborating with cross‑functional teams to determine the scope of field actions and facilitate HRAs or HHEs to assess clinical risk.
Partner with cross‑functional teams to develop and deliver clear, data‑driven presentations to the committee deciding field actions, supporting alignment on impact assessments, scope definition, and mitigation strategies.
Draft and coordinate responses to FDA warning letters, field‑action inquiries, and other regulatory correspondence, ensuring timely and accurate updates on mitigation activities.
Drive end‑to‑end process improvements throughout the quality system by identifying inefficiencies, streamlining processes, enhancing compliance, and improving overall performance.
Support successful execution of field corrective actions by ensuring solutions are available, validated, accurately released, and fully aligned with applicable regulations and standards.
Leverage data analytics to uncover opportunities for benchmark and KDG refinements by analyzing quality trends, monitoring performance indicators, detecting systemic issues, and proposing targeted improvements, leading management meetings to evaluate metrics and align on improvement strategies.
Background and Experience
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 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: ISO 13485, ISO 9001, 21 CFR Part 820, EU MDR.
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.
Why Join Us? At BD, you’ll discover a culture that values your opinions, encourages authenticity, and supports learning and growth. We provide opportunities to innovate, hold each other accountable, and improve continuously while contributing to the future of health. Join us and help turn the impossible into transformative solutions.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively. The salary or hourly pay offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location.
Salary Range: $155,900.00 – $257,300.00 USD Annual
Seniority Level: Mid‑Senior level
Employment Type: Full‑time
Job Function: Quality Assurance
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.
Remote and field‑based positions may have different workplace arrangements indicated in the posting. Vaccination requirements may apply as per the company's policy.
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Job Description Summary The Quality Systems and Regulatory Staff Lead ensures 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. The Lead delivers data‑driven insights for decision‑making, 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.
Key Responsibilities
Support the development, execution, and governance of remediation and prevention strategies as well as post‑market issue impact/risk assessments, ensuring alignment with regulatory requirements and internal quality standards.
Evaluate potential issues before formal CAPA initiation through structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted, prioritizing and risk‑ranking issues based on impact and recurrence.
Confirm that CAPA investigations are directly tied to the reason for the recall and that corrective and preventive actions are appropriate, mitigating risks, with robust implementation plans and verification of effectiveness (VOE) plans.
Support comprehensive issue impact and risk evaluations (SAs) and apply a risk‑based method to prioritize issues for the field action committee, facilitating discussions with medical affairs and other relevant functions.
Ensure HRA or HHE alignment by collaborating with cross‑functional teams to determine the scope of field actions and facilitate HRAs or HHEs to assess clinical risk.
Partner with cross‑functional teams to develop and deliver clear, data‑driven presentations to the committee deciding field actions, supporting alignment on impact assessments, scope definition, and mitigation strategies.
Draft and coordinate responses to FDA warning letters, field‑action inquiries, and other regulatory correspondence, ensuring timely and accurate updates on mitigation activities.
Drive end‑to‑end process improvements throughout the quality system by identifying inefficiencies, streamlining processes, enhancing compliance, and improving overall performance.
Support successful execution of field corrective actions by ensuring solutions are available, validated, accurately released, and fully aligned with applicable regulations and standards.
Leverage data analytics to uncover opportunities for benchmark and KDG refinements by analyzing quality trends, monitoring performance indicators, detecting systemic issues, and proposing targeted improvements, leading management meetings to evaluate metrics and align on improvement strategies.
Background and Experience
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 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: ISO 13485, ISO 9001, 21 CFR Part 820, EU MDR.
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.
Why Join Us? At BD, you’ll discover a culture that values your opinions, encourages authenticity, and supports learning and growth. We provide opportunities to innovate, hold each other accountable, and improve continuously while contributing to the future of health. Join us and help turn the impossible into transformative solutions.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively. The salary or hourly pay offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location.
Salary Range: $155,900.00 – $257,300.00 USD Annual
Seniority Level: Mid‑Senior level
Employment Type: Full‑time
Job Function: Quality Assurance
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.
Remote and field‑based positions may have different workplace arrangements indicated in the posting. Vaccination requirements may apply as per the company's policy.
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