About this role
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:
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Development of project timelines
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Project team assembly
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Managing the schedule
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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
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Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR)
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Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle
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Demonstrated hands-on experience with QMS process areas
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Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes
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Demonstrated experience leading complex, multi-workstream projects within a formal project management framework
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Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials
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Experience managing cross-functional teams in a matrixed organizational environment
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Excellent written and verbal communication skills
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Proven ability to influence, align, and lead cross-functional stakeholders
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Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments
Requirements
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Bachelor’s degree in engineering, Life Sciences, Quality, Business Administration, or a related field required
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Master’s degree or advanced technical credential a plus
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Minimum 5 years of experience in project or program management roles within the medical device industry
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Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485
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Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions is strongly preferred
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PMP (Project Management Professional) certification is highly desired
Benefits
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Health, Dental, and Vision insurance benefits
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401k plan with company match
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Paid Time Off
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Wellness initiative & Health Assistance Resources
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Life Insurance
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Short and Long Term Disability Benefits
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Health and Dependent Care Flexible Spending Accounts
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Commuter Benefits
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Parental and Caregiver Leave
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Tuition Reimbursement