Project Manager, Quality Assurance – Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the planning, execution, and delivery of strategic initiatives within Quality and Regulatory Affairs.

• Manage the implementation of electronic Quality Management Systems (eQMS), remediation programs for QMS, integration of quality systems, process harmonization projects, and compliance-driven transformations.

• Create and uphold project plans, resource forecasts, budgets, timelines, risk registers, and governance frameworks.

• Identify, manage, and escalate project risks, regulatory impacts, resource limitations, and quality-related concerns.

• Set up and track KPIs, dashboards, and executive reporting metrics.

• Relay project status, risks, resource requirements, and recommendations to senior leadership.

• Direct Quality and Regulatory integration activities during mergers, acquisitions, divestitures, site transfers, and organizational changes.

• Facilitate governance meetings, steering committee evaluations, and executive briefings.

• Advocate for best practices in project management, quality systems, and regulatory compliance.

• Participate in FDA, Notified Body, and internal Good Manufacturing Practice (GMP) audits and inspections.

• Engage in special projects and undertake additional responsibilities as assigned.

• Provide informal mentorship to less-experienced team members as necessary.

⛳️ Requirements

• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams).

• Familiarity with Visio, Access, Power BI, and SharePoint is advantageous.

• Experience with electronic applications for quality systems is a plus.

• Knowledge of the European Union Medical Device Regulation (EU MDR).

• PMP certification is preferred.

• Proven ability to lead and manage teams while enhancing processes effectively and efficiently.

• Demonstrated success in leading quality improvement initiatives.

• Capability to resolve issues through critical thinking and root-cause analysis with minimal guidance.

• Ability to prioritize tasks, manage multiple responsibilities, and adapt to changes.

• Strong teamwork skills with the ability to build effective working relationships.

• Experience leading audits and engaging with third-party regulatory bodies, including Notified Bodies and the FDA.

• Typically requires 5 or more years of progressively responsible and complex professional experience.

• At least 1 year of project management experience is preferred.

• Experience in the medical devices sector is essential.

• In-depth knowledge of QMSR, ISO 13485, MDSAP, and EU MDR.

• A Bachelor's degree or its global equivalent in a relevant field is preferred.

• Must be fully vaccinated against COVID-19 in accordance with applicable state/local regulations.

• Travel is generally less than 10%.

• Office-based environment; no special physical requirements are necessary.

🏝️ 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.