Remote Project Manager, QMS & Regulatory Excellence

Getinge; Charleston (WV); 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 is looking for a Project Manager - Quality and Regulatory to lead initiatives aimed at enhancing the Quality Management System. This remote position requires candidates to reside in Eastern Standard Time and involves managing cross-functional teams to ensure project milestones are met.

The ideal candidate should have expertise in FDA regulations, ISO standards, and a minimum of 5 years in project management within the medical device field. Benefits include health insurance and 401k matching.

Qualifications

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

Responsibilities

• Lead QMS projects and manage project schedules.
• Develop project timelines and maintain effective communication.
• Support gap closure documentation and audit readiness.

Skills

FDA 21 CFR Part 820 knowledge

ISO 13485:2016 understanding

Project management methodology

Microsoft Project proficiency

Cross-functional team management

Education

Bachelor’s degree in engineering or related field

Tools

Microsoft 365 (Teams, SharePoint, Excel)

Job description

Getinge is looking for a Project Manager - Quality and Regulatory to lead initiatives aimed at enhancing the Quality Management System. This remote position requires candidates to reside in Eastern Standard Time and involves managing cross-functional teams to ensure project milestones are met.

The ideal candidate should have expertise in FDA regulations, ISO standards, and a minimum of 5 years in project management within the medical device field. Benefits include health insurance and 401k matching.