Remote Project Manager, QMS & Regulatory Excellence

Getinge; Hartford (CT); 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 seeking a Project Manager - Quality and Regulatory in Hartford, Connecticut. The role involves leading QMS enhancement projects, managing cross-functional teams, and ensuring compliance with regulatory standards such as FDA 21 CFR Part 820 and ISO 13485:2016.

Candidates should have at least 5 years in project management within the medical device industry, strong regulatory knowledge, and proficiency in project management tools. This is a remote position with occasional domestic travel required.

Qualifications

• Minimum 5 years of experience in project management roles.
• Experience implementing or managing QMS projects under FDA 21 CFR Part 820.
• PMP certification is highly desired.

Responsibilities

• Own integrated project schedule and milestone tracking.
• Develop and maintain project-level RAID logs.
• Lead project coordination across various QMS enhancement areas.

Skills

Expert-level knowledge of FDA 21 CFR Part 820

Strong understanding of ISO 13485:2016

Project management experience

Ability to influence cross-functional teams

Proficiency in Microsoft Project

Education

Bachelor’s degree in engineering or related field

Tools

Microsoft Project

Smartsheet

Monday.com

Job description

Getinge is seeking a Project Manager - Quality and Regulatory in Hartford, Connecticut. The role involves leading QMS enhancement projects, managing cross-functional teams, and ensuring compliance with regulatory standards such as FDA 21 CFR Part 820 and ISO 13485:2016.

Candidates should have at least 5 years in project management within the medical device industry, strong regulatory knowledge, and proficiency in project management tools. This is a remote position with occasional domestic travel required.