Medical Device Program Manager Regulatory Lead

Garmin; Olathe (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Garmin Benefits

Job summary

Garmin, based in Olathe, KS, seeks a full-time Program Manager Medical Devices to lead regulatory-driven product lifecycle activities and coordinate cross-functional teams in a fast-paced environment.

The role involves driving regulatory documentation, QMS coordination, risk management, and study support while mentoring junior PMs and collaborating with multiple Garmin teams to ensure timely product approvals and compliant delivery.

Qualifications

• Bachelor's degree in a technical discipline with 2+ years of relevant experience.
• Demonstrates ability to analyze problems, engage stakeholders and execute.
• Knowledge of medical device regulation and QMS requirements.

Responsibilities

• Lead regulatory and lifecycle activities for medical devices.
• Coordinate QMS activities to meet milestones.
• Prepare regulatory submissions for market approvals.
• Support usability/clinical study activities.
• Develop and maintain project timelines and KPIs.
• Mentor PM Level 1 and lead program initiatives.

Skills

Program management

Regulatory knowledge

Leadership

Mentoring

Education

Bachelor's Degree in a technical discipline

Job description

Garmin, based in Olathe, KS, seeks a full-time Program Manager Medical Devices to lead regulatory-driven product lifecycle activities and coordinate cross-functional teams in a fast-paced environment.

The role involves driving regulatory documentation, QMS coordination, risk management, and study support while mentoring junior PMs and collaborating with multiple Garmin teams to ensure timely product approvals and compliant delivery.