Remote Project Manager, QMS & Regulatory Excellence

Getinge; Boston (MA); 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 searching for a Project Manager - Quality and Regulatory located in the United States, Massachusetts, Boston, to lead QMS enhancement initiatives. This role involves serving as the primary driver of projects execution across various QMS workstreams, coordinating cross-functional teams and ensuring project deliverables.

The ideal candidate will have significant experience in managing complex QMS projects within the medical device industry and will need to demonstrate excellent communication and organizational skills.

Qualifications

• Minimum 5 years of experience in project or program management roles within the medical device industry.
• Minimum 3 years of hands-on experience implementing or managing QMS projects.
• PMP (Project Management Professional) certification is highly desired.

Responsibilities

• Own an integrated schedule and milestone tracking for QMS workstreams.
• Facilitate reviews and workstream-level sessions with stakeholders.
• Develop and present structured status reports to project teams.

Skills

Expert-level working knowledge of FDA 21 CFR Part 820

Strong applied understanding of ISO 13485:2016

Experience with QMS process areas

Familiarity with ISO 14971

Experience leading complex projects

Ability to manage integrated project schedules

Excellent communication skills

Strong organizational skills

Education

Bachelor’s degree in engineering, Life Sciences, Quality

Master’s degree or advanced technical credential

Tools

Microsoft Project

Microsoft 365

Job description

Getinge is searching for a Project Manager - Quality and Regulatory located in the United States, Massachusetts, Boston, to lead QMS enhancement initiatives. This role involves serving as the primary driver of projects execution across various QMS workstreams, coordinating cross-functional teams and ensuring project deliverables.

The ideal candidate will have significant experience in managing complex QMS projects within the medical device industry and will need to demonstrate excellent communication and organizational skills.