BD · 2 weeks ago
Quality Systems & Regulatory Staff Lead
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Senior Level, Lead/Staff
$156K/yr - $257K/yr
7+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Quality Systems and Regulatory Staff Lead ensures effective governance of post-market quality processes, manages regulatory communications, and drives continuous improvement within the quality system to uphold product safety and compliance.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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
Benefits
Health Insurance
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase