Remote Project Manager — QMS & Regulatory Initiatives

Getinge; Wayne (NJ); On-site; 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 is hiring a Project Manager – Quality and Regulatory to lead projects focused on enhancing the Quality Management System (QMS). This remote position requires significant experience in the medical device industry, project management under FDA regulations, and strong leadership skills.

The ideal candidate will coordinate with various teams, manage schedules, and ensure all project deliverables meet regulatory requirements. Strong communication and organizational skills are essential. Competitive salary and comprehensive benefits offered.

Qualifications

• Proven ability to manage QMS projects under FDA 21 CFR Part 820.
• Minimum 5 years in project management roles in the medical device industry.
• Experience in leading complex projects.

Responsibilities

• Own QMS project schedules, track milestones.
• Develop RAID logs and status reports.
• Facilitate cross-functional working sessions.

Skills

Expert knowledge of FDA 21 CFR Part 820

Strong understanding of ISO 13485:2016

Project management skills

Communication skills

Organizational skills

Education

Bachelor's degree in engineering or related field

Master's degree preferred

Tools

Microsoft Project

Microsoft 365

Job description

Getinge is hiring a Project Manager – Quality and Regulatory to lead projects focused on enhancing the Quality Management System (QMS). This remote position requires significant experience in the medical device industry, project management under FDA regulations, and strong leadership skills.

The ideal candidate will coordinate with various teams, manage schedules, and ensure all project deliverables meet regulatory requirements. Strong communication and organizational skills are essential. Competitive salary and comprehensive benefits offered.