Remote Project Manager, QMS & Regulatory Excellence

Getinge; Miami (FL); 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 is looking for a Project Manager - Quality and Regulatory to lead QMS enhancement initiatives. This remote role requires expertise in FDA regulations and project management. Key responsibilities include managing timelines, collaborating with teams, and ensuring regulatory compliance.

The ideal candidate has a Bachelor’s degree in engineering or Life Sciences, a minimum of 5 years of experience in the medical device industry, and is PMP certified. Salary range: $120,160 - $150,000 per year.

Qualifications

• Minimum 5 years of experience in project management in medical device industry.
• Minimum 3 years managing QMS projects under FDA regulations.
• PMP certification strongly preferred.

Responsibilities

• Lead project management for QMS enhancement initiatives.
• Develop integrated project schedules and manage resources.
• Collaborate across functions to ensure regulatory compliance.

Skills

Expert-level knowledge of FDA 21 CFR Part 820

Understanding of ISO 13485:2016 QMS requirements

Experience with QMS process areas (CAPA, DHRs)

Strong communication skills

Project management experience

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced credential

Tools

Microsoft Project

Microsoft 365 (Teams, SharePoint, Excel)

Job description

Getinge is looking for a Project Manager - Quality and Regulatory to lead QMS enhancement initiatives. This remote role requires expertise in FDA regulations and project management. Key responsibilities include managing timelines, collaborating with teams, and ensuring regulatory compliance.

The ideal candidate has a Bachelor’s degree in engineering or Life Sciences, a minimum of 5 years of experience in the medical device industry, and is PMP certified. Salary range: $120,160 - $150,000 per year.