Remote Project Manager, QMS & Regulatory Excellence

Getinge; Wayne (NJ); Remote; USD 120,160 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance benefits

401k plan with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge in Wayne, NJ is looking for a Project Manager - Quality and Regulatory to lead Quality Management System (QMS) projects. The role includes project coordination across multiple workstreams and compliance management with FDA and ISO regulations. Candidates must have expertise in QMS processes and strong project management skills.

This position offers a remote work opportunity but candidates should be located in the Eastern Standard Time zone. The salary ranges from $120,160 to $150,000 per year, commensurate with experience.

Qualifications

• Minimum 5 years of project management experience in medical devices.
• 3 years of hands-on QMS project management.
• PMP certification is highly desired.

Responsibilities

• Lead and coordinate QMS enhancement projects.
• Manage schedules, status reporting, and RAID logs.
• Ensure compliance with FDA and ISO regulations.

Skills

Expert knowledge of FDA 21 CFR Part 820

Project Management Institute (PMI) methods

ISO 13485:2016 requirements

Microsoft Project

Microsoft 365 (Teams, SharePoint, Excel)

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced technical credential

Job description

Getinge in Wayne, NJ is looking for a Project Manager - Quality and Regulatory to lead Quality Management System (QMS) projects. The role includes project coordination across multiple workstreams and compliance management with FDA and ISO regulations. Candidates must have expertise in QMS processes and strong project management skills.

This position offers a remote work opportunity but candidates should be located in the Eastern Standard Time zone. The salary ranges from $120,160 to $150,000 per year, commensurate with experience.