Project Manager, Quality Assurance – Regulatory Affairs

Job not on LinkedIn

🔥 3 minutes ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Henry Schein

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1932

🏥 Healthcare

🍽️ Food & Beverage

🏭 Manufacturing

Healthcare • Food & Beverage • Manufacturing

Henry Schein is a global company dedicated to servicing a range of medical and dental providers. It offers a comprehensive portfolio of products and solutions, including practice management software, large equipment, and technology services. Founded in 1932, Henry Schein has established itself as a leader in healthcare products and services, with a commitment to improving health and increasing access to care through strategic growth and innovation across its global operations.

📋 Description

• Lead planning, execution and delivery of strategic Quality and Regulatory Affairs initiatives • Manage eQMS implementations, QMS remediation programs, quality system integrations, process harmonization projects and compliance-driven transformations • Develop and maintain project plans, resource forecasts, budgets, timelines, risk registers and governance frameworks • Assess, manage and escalate project risks, regulatory impacts, resource constraints and quality-related issues • Establish and monitor KPIs, dashboards and executive reporting metrics • Communicate project health, risks, resource needs and recommendations to senior leadership • Lead Quality and Regulatory integration activities for mergers, acquisitions, divestitures, site transfers and organizational transformations • Facilitate governance meetings, steering committee reviews and executive updates • Promote project management, quality systems and regulatory compliance best practices • Participate in FDA, Notified Body and internal GMP audits and inspections • Participate in special projects and perform other duties as required • Provide informal guidance to less-experienced team members as needed

🎯 Requirements

• Proficiency in the Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams) • Working knowledge of Visio, Access, Power BI and SharePoint is a plus • Experience using quality system electronic applications is a plus • Knowledge of EU MDR • PMP certification desired • Demonstrated ability to lead and manage employees while driving effective and efficient processes • Demonstrated record of successfully leading quality improvement projects • Ability to solve problems through critical thinking and root-cause analysis with minimal direction • Ability to prioritize, multitask and adapt to change • Ability to work effectively in a team environment and build strong working relationships • Experience leading audits and interactions with third-party regulatory agencies, including Notified Bodies and the FDA • Typically 5 or more years of increasing responsibility and complexity in applicable professional experience • 1 or more years of project management experience desired • Medical devices experience required • Thorough knowledge of QMSR, ISO 13485, MDSAP and EU MDR • Bachelor's degree or global equivalent in a related discipline is preferred • Fully vaccinated against COVID-19 pursuant to applicable state/local law • Travel typically less than 10% • Office environment; no special physical demands required

🏖️ Benefits

• Medical, Dental and Vision Coverage • 401K Plan with Company Match • Generous Time Off • Paid Parental Leave • Income Protection • Work Life Assistance Program • Flexible Spending Accounts • Educational Benefits • Worldwide Scholarship Program • Volunteer Opportunities