Remote Project Manager, QMS & Regulatory Excellence

Getinge; Providence (RI); 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

Tuition Reimbursement

Job summary

Getinge is seeking a Project Manager - Quality and Regulatory located in the Eastern Time Zone. The role involves leading QMS enhancement projects, collaborating with cross-functional teams, and ensuring compliance with FDA regulations. The perfect candidate will have over 5 years of medical device project management experience, with knowledge of FDA 21 CFR Part 820 and ISO 13485:2016.

The salary range is between $120,160 to $150,000 per year, based on experience, and comes with generous benefits including health insurance and a 401k plan.

Qualifications

• Minimum 5 years of experience in project management in the medical device industry.
• Hands-on experience implementing QMS projects under FDA regulations.
• PMP certification is highly desired.

Responsibilities

• Lead project management for QMS enhancement initiatives.
• Coordinate cross-functional teams and manage project timelines.
• Develop and maintain project-level reports and dashboards.

Skills

FDA 21 CFR Part 820 knowledge

ISO 13485:2016 understanding

Project management methodology

Microsoft Project proficiency

Excellent communication skills

Education

Bachelor’s degree in engineering, Life Sciences, Quality, or related field

Tools

Microsoft 365

Job description

Getinge is seeking a Project Manager - Quality and Regulatory located in the Eastern Time Zone. The role involves leading QMS enhancement projects, collaborating with cross-functional teams, and ensuring compliance with FDA regulations. The perfect candidate will have over 5 years of medical device project management experience, with knowledge of FDA 21 CFR Part 820 and ISO 13485:2016.

The salary range is between $120,160 to $150,000 per year, based on experience, and comes with generous benefits including health insurance and a 401k plan.