QARA Project Manager

Position Summary

The Project Manager is responsible for planning, coordinating, and executing projects that support Quality Assurance and Regulatory Affairs (QARA) initiatives. This role partners closely with cross functional teams and IT to ensure project requirements, timelines, and deliverables are clearly defined and successfully achieved. The Project Manager helps drive implementation of quality and regulatory projects by maintaining structured project plans, supporting team collaboration, monitoring progress, and ensuring adherence to compliance requirements.

Principal Responsibilities

•    Partner with QARA leaders and subject matter experts to translate initiatives into project charters, define scope, and obtain required approvals. 
•    Develop, maintain, and communicate project schedules, deliverables, milestones, and workstream plans. 
•    Track day to day project progress, including tasks, risks, dependencies, budget considerations, and resource needs. 
•    Lead and facilitate cross functional project meetings, ensuring effective collaboration and timely decision making. Document meeting minutes, actions, decisions, and risks. 
•    Maintain project documentation, including schedules, status updates, dashboards, and risk/issue logs. 
•    Partner with functional teams—including Regulatory, Design Assurance, Quality Operations, Product Quality, and QMS—to document business requirements and support the development of systems and IT tools. 
•    Support compliance with relevant quality and regulatory standards by ensuring project tasks and deliverables are properly completed and documented. 
•    Facilitate proactive risk management, including identification, assessment, mitigation planning and escalation of project and compliance risks. 
•    Communicate status updates, risks, and key issues to leadership on a regular basis, escalating concerns when needed. 
•    Collaborate with other project managers to coordinate timelines, align work efforts, and promote efficient use of shared resources. 
•    Utilize project management tools and standard processes to support consistent execution and reporting. 
•    Facilitate regular meetings, capture action items, and follow up with stakeholders to ensure timely completion of assigned tasks.

Education / Experience Requirements

•    Bachelor’s degree in a business or science discipline or equivalent education/experience required.
•    Minimum 2-4 years project management experience in the medical device and/or FDA-regulated industry.
•    Minimum 4 years project management experience in large organizations with national or global operations.
•    PMP certification preferred (or in process)
•    Knowledge and application of a structured project management process.
•    Six Sigma certifications are a plus.

Specialized Skills / Other Requirements

•    Excellent written and verbal communication skills; able to clearly communicate with various levels of the organization.
•    Strong collaboration and teamwork skills, with the ability to build productive relationships across functions.
•    Ability to influence without authority and partner effectively in a matrix environment.
•    Strong organizational skills with the ability to manage multiple projects, prioritize work, and meet deadlines.
•    Proficiency with project management tools such as MS Project, Excel, PowerPoint, and SharePoint.
•    Strong analytical, planning, and problem‑solving skills; attentive to detail.
•    Ability to support decision‑making and help drive alignment across cross‑functional stakeholders.
•    Experience in Regulatory Affairs, Quality Assurance, or project management within a regulated industry required.
•    Proven ability to adapt to shifting priorities and manage competing demands.

Success Metrics / KPIs
•    On time, in scope delivery of project milestones.
•    Project transparency and stakeholder satisfaction (leadership and functional teams).
•    Cost/schedule performance indices; benefits realization vs. business case.
•    Adoption and sustainment metrics (training completion, process adherence, effectiveness checks).

Working Model
•    Global, cross functional role supporting multiple business units; occasional early/late meetings to accommodate time zones.
•    Hybrid/remote flexibility with travel to sites, notified bodies, suppliers, or regulators as business needs dictate.

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