Remote Project Manager, QMS & Regulatory Excellence

Getinge; Richmond (VA); 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

Job summary

Getinge is seeking a Project Manager - Quality and Regulatory to lead QMS enhancement projects. The role involves managing cross-functional teams, developing project timelines, and coordinating various workstreams. Candidates must reside in Eastern Standard Time and ideally have a background in engineering or life sciences.

Responsibilities include ensuring compliance with FDA regulations, managing QMS process areas, and developing structured reports. A minimum of 5 years of relevant experience is required, along with a bachelor's degree in a related field.

The position is remote with a salary range of $120,160 to $150,000 per year, depending on experience.

Qualifications

• Minimum 5 years in project management in the medical device industry.
• Experience with QMS projects under FDA 21 CFR Part 820.
• PMP certification is highly desired.

Responsibilities

• Manage integrated schedules and milestone tracking for QMS projects.
• Develop and maintain project-level RAID logs and status dashboards.
• Lead project coordination across multiple QMS enhancement areas.

Skills

Expert-level knowledge of FDA 21 CFR Part 820

Strong understanding of ISO 13485:2016

Experience with QMS process areas

Advanced project management skills

Excellent communication skills

Ability to manage cross-functional teams

Education

Bachelor's degree in relevant field

Master's degree or advanced technical credential

Tools

Microsoft Project

Microsoft 365

Job description

Getinge is seeking a Project Manager - Quality and Regulatory to lead QMS enhancement projects. The role involves managing cross-functional teams, developing project timelines, and coordinating various workstreams. Candidates must reside in Eastern Standard Time and ideally have a background in engineering or life sciences.

Responsibilities include ensuring compliance with FDA regulations, managing QMS process areas, and developing structured reports. A minimum of 5 years of relevant experience is required, along with a bachelor's degree in a related field.

The position is remote with a salary range of $120,160 to $150,000 per year, depending on experience.