Project Manager, Quality Assurance – Regulatory Affairs
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Job Description
Project Manager leading QA/RA initiatives for Henry Schein’s medical device businesses. Managing quality systems, regulatory compliance, audits and transformation projects.
Responsibilities:
- 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
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