Remote Project Manager, QMS & Regulatory Excellence

Getinge; New York (NY); 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

Wellness initiative & Health Assistance Resources

Life Insurance

Short and Long Term Disability Benefits

Tuition Reimbursement

Job summary

Getinge is seeking a Project Manager specializing in Quality Management Systems to lead critical projects aimed at enhancing QMS initiatives over a term of approximately 12 months. In this remote role, the successful candidate will own an integrated schedule and facilitate cross-functional collaboration to meet critical milestones.

The ideal candidate should possess extensive knowledge of FDA regulations and ISO 13485, alongside proven project management experience. A Bachelor’s degree and PMP certification are preferred. Competitive salary and comprehensive benefits are provided.

Qualifications

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

Responsibilities

• Lead project coordination across QMS enhancement areas.
• Develop and maintain project-level RAID logs and status dashboards.
• Maintain effective communication through project deliverables.

Skills

Project Management

FDA Regulations

ISO Standards

Communication Skills

Risk Management

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced technical credential

Tools

Microsoft Project

Smartsheet

Monday.com

Microsoft 365

Job description

Getinge is seeking a Project Manager specializing in Quality Management Systems to lead critical projects aimed at enhancing QMS initiatives over a term of approximately 12 months. In this remote role, the successful candidate will own an integrated schedule and facilitate cross-functional collaboration to meet critical milestones.

The ideal candidate should possess extensive knowledge of FDA regulations and ISO 13485, alongside proven project management experience. A Bachelor’s degree and PMP certification are preferred. Competitive salary and comprehensive benefits are provided.