Remote Project Manager, QMS & Regulatory Excellence

Getinge; Augusta (ME); 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

Tuition Reimbursement

Job summary

Getinge in Augusta, ME is looking for a Project Manager - Quality and Regulatory to coordinate key projects aimed at enhancing Quality Management Systems. This remote position requires expertise in FDA regulations, ISO standards, and proven project management skills.

The ideal candidate will have a strong background in medical devices, excellent communication skills, and a detail-oriented approach. Competitive salary between $120,160 to $150,000 per year along with comprehensive health insurance benefits.

Qualifications

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

Responsibilities

• Lead QMS enhancement projects and manage schedules.
• Apply PMI-based project management methodologies.
• Collaborate with cross-functional teams and stakeholders.

Skills

Expert-level working knowledge of FDA 21 CFR Part 820

Strong applied understanding of ISO 13485:2016

Experience with QMS process areas

Excellent communication skills

Strong organizational skills

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced credential

Tools

Microsoft Project

Microsoft 365

Job description

Getinge in Augusta, ME is looking for a Project Manager - Quality and Regulatory to coordinate key projects aimed at enhancing Quality Management Systems. This remote position requires expertise in FDA regulations, ISO standards, and proven project management skills.

The ideal candidate will have a strong background in medical devices, excellent communication skills, and a detail-oriented approach. Competitive salary between $120,160 to $150,000 per year along with comprehensive health insurance benefits.