Remote Project Manager — QMS & Regulatory

MaineGuide; Augusta, Northern (ME, KY); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance

401k with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge seeks a Project Manager - Quality and Regulatory to drive QMS enhancement initiatives across multiple workstreams. You will manage timelines, build project teams, track milestones, and report to leadership.

This is a defined-term role for approximately 12 months, with remote work while residing in Eastern Standard Time. Responsibilities include leading cross-functional coordination, applying PMI-based practices, maintaining RAID logs, and delivering executive-level status reports.

Qualifications

• Bachelor's degree in engineering, Life Sciences, Quality, or Business Administration required.
• Minimum 5 years of project/program management in the medical device industry.
• Experience with FDA 21 CFR Part 820 and ISO 13485 in regulated medical devices.
• PMP certification highly desired.

Responsibilities

• Lead and coordinate QMS-focused projects with cross-functional teams.
• Develop and maintain project schedules, RAID logs, and executive dashboards.
• Escalate risks and issues with recommended resolutions.
• Support PMO tooling, templates and governance in Healthmark's program.
• Ensure deliverables comply with FDA/ISO requirements.

Skills

QMS & FDA knowledge

PMI PMBOK methods

Cross-functional leadership

Regulatory compliance

MS Project / scheduling tools

Education

Bachelor's degree in engineering/related field

Master's degree or advanced credential (plus)

Tools

Microsoft Project

Smartsheet

Monday.com

SharePoint / Excel

Job description

Getinge seeks a Project Manager - Quality and Regulatory to drive QMS enhancement initiatives across multiple workstreams. You will manage timelines, build project teams, track milestones, and report to leadership.

This is a defined-term role for approximately 12 months, with remote work while residing in Eastern Standard Time. Responsibilities include leading cross-functional coordination, applying PMI-based practices, maintaining RAID logs, and delivering executive-level status reports.