Remote Project Manager, QMS & Regulatory Excellence

Getinge; Atlanta (GA); Remote; USD 120,160 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Life Insurance

Job summary

Getinge in Atlanta, Georgia is seeking a Project Manager for Quality and Regulatory to lead Quality Management System enhancement initiatives. This role involves managing multiple QMS workstreams, developing timelines, and facilitating collaboration among cross-functional teams.

Candidates should have a strong background in FDA regulations and ISO standards, along with experience in project management within the medical device industry. The position allows for remote work, but applicants must be in the Eastern Standard Time zone.

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Qualifications

• 5+ years of experience in project management in the medical device industry.
• 3+ years of direct experience managing QMS projects under FDA and ISO standards.
• PMP certification is highly desired.

Responsibilities

• Lead project management activities for QMS enhancement.
• Develop and maintain project schedules and RAID logs.
• Facilitate cross-functional collaboration and communication.

Skills

Expert knowledge of FDA 21 CFR Part 820

Knowledge of ISO 13485:2016

Project management methodologies (PMI)

Cross-functional team leadership

Strong communication skills

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced credential

Tools

Microsoft Project

Smartsheet

Monday.com

Job description

Getinge in Atlanta, Georgia is seeking a Project Manager for Quality and Regulatory to lead Quality Management System enhancement initiatives. This role involves managing multiple QMS workstreams, developing timelines, and facilitating collaboration among cross-functional teams.

Candidates should have a strong background in FDA regulations and ISO standards, along with experience in project management within the medical device industry. The position allows for remote work, but applicants must be in the Eastern Standard Time zone.

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