Remote Project Manager, QMS & Regulatory Excellence

Getinge; Dover (DE); 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 is hiring a Project Manager - Quality and Regulatory to lead QMS enhancement initiatives. The role involves coordinating projects while ensuring compliance with FDA regulations. The right candidate will manage cross-functional teams, develop timelines, and maintain communication throughout the project lifecycle.

With a focus on quality management systems, candidates with experience in the medical device industry and project management credentials are encouraged to apply. Remote work is available, but candidates should reside in Eastern Standard Time.

Qualifications

• Minimum of 5 years of experience in project management within the medical device industry.
• Minimum of 3 years handling QMS projects under FDA 21 CFR Part 820 and/or ISO 13485.
• PMP certification is highly desired.

Responsibilities

• Manage integrated project schedules and milestones across QMS workstreams.
• Facilitate project coordination with cross-functional teams.
• Develop and present structured status reports to senior leadership.

Skills

Expert-level knowledge of FDA 21 CFR Part 820

Project management methods (PMI)

Experience in cross-functional team management

Strong communication skills

Proficiency in Microsoft Project

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced technical credential

Tools

Microsoft Project

Smartsheet

Monday.com

Job description

Getinge is hiring a Project Manager - Quality and Regulatory to lead QMS enhancement initiatives. The role involves coordinating projects while ensuring compliance with FDA regulations. The right candidate will manage cross-functional teams, develop timelines, and maintain communication throughout the project lifecycle.

With a focus on quality management systems, candidates with experience in the medical device industry and project management credentials are encouraged to apply. Remote work is available, but candidates should reside in Eastern Standard Time.