Remote Project Manager, QMS & Regulatory Excellence

Getinge; Baltimore (MD); Remote; USD 120,160 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge in Baltimore, MD is seeking an experienced Project Manager - Quality and Regulatory to lead and coordinate Quality Management System (QMS) enhancement initiatives. This position, defined for approximately 12 months and remote, demands excellent project management skills and regulatory knowledge.

Key responsibilities include managing project schedules, facilitating cross-functional collaboration, and ensuring project deliverables meet FDA and ISO requirements. A Bachelor's degree and extensive experience in the medical device industry are required.

Qualifications

• Minimum 5 years of experience in project management within the medical device industry.
• Minimum 3 years managing QMS projects under FDA 21 CFR Part 820.
• PMP (Project Management Professional) certification is highly desired.

Responsibilities

• Manage integrated schedule, milestone tracking, and status reporting across QMS workstreams.
• Develop and maintain project-level RAID logs and dashboards.
• Collaborate with QA and Regulatory Affairs to ensure project deliverables meet regulations.

Skills

FDA 21 CFR Part 820 knowledge

Project management methodologies

Cross-functional team management

Regulatory compliance

Microsoft Project

Education

Bachelor’s degree in engineering or related field

Tools

Microsoft 365

Smartsheet

Job description

Getinge in Baltimore, MD is seeking an experienced Project Manager - Quality and Regulatory to lead and coordinate Quality Management System (QMS) enhancement initiatives. This position, defined for approximately 12 months and remote, demands excellent project management skills and regulatory knowledge.

Key responsibilities include managing project schedules, facilitating cross-functional collaboration, and ensuring project deliverables meet FDA and ISO requirements. A Bachelor's degree and extensive experience in the medical device industry are required.