Project Manager - Quality and Regulatory

Role Description

The Project Manager – Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include:

• Development of project timelines
• Project team assembly
• Managing the schedule
• Maintaining effective communication through the project

This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.

Qualifications

• Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR)
• Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle
• Demonstrated hands-on experience with QMS process areas
• Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes
• Demonstrated experience leading complex, multi-workstream projects within a formal project management framework
• Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials
• Experience managing cross-functional teams in a matrixed organizational environment
• Excellent written and verbal communication skills
• Proven ability to influence, align, and lead cross-functional stakeholders
• Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments

Requirements

• Bachelor’s degree in engineering, Life Sciences, Quality, Business Administration, or a related field required
• Master’s degree or advanced technical credential a plus
• Minimum 5 years of experience in project or program management roles within the medical device industry
• Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485
• Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions is strongly preferred
• PMP (Project Management Professional) certification is highly desired

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement