Regulatory Affairs Director: Cardio Medical Devices

Medtronic; Mounds View (MN); On-site; USD 180,000 - 230,000; Full time

Job summary

Medtronic in Mounds View, MN seeks a Regulatory Affairs Director to lead regulatory strategy and execution across CDS and PCS in the Electrophysiology Therapies unit. You will direct regulatory submissions, audits, and inspections, and shape strategies aligning with business goals.

The role requires deep regulatory expertise, strong leadership skills, and ability to influence cross-functional teams to achieve timely approvals and compliant outcomes.

Qualifications

• Bachelor's degree required in a relevant field.
• 10+ years of medical device regulatory affairs experience, including 7+ years of managerial experience.
• An advanced degree with 8+ years of regulatory affairs experience is acceptable.

Responsibilities

• Direct regulatory strategy and execution across CDS/PCS in the EPT OU.
• Lead regulatory submission activities, audits, and inspections.
• Influence cross-functional stakeholders to achieve timely regulatory outcomes.

Skills

Regulatory leadership

Strategic planning

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree

Advanced degree (preferred)

Job description

Medtronic in Mounds View, MN seeks a Regulatory Affairs Director to lead regulatory strategy and execution across CDS and PCS in the Electrophysiology Therapies unit. You will direct regulatory submissions, audits, and inspections, and shape strategies aligning with business goals.

The role requires deep regulatory expertise, strong leadership skills, and ability to influence cross-functional teams to achieve timely approvals and compliant outcomes.