Sr. Manager, Recalls/Field Corrective Actions

Medtronic • Northridge, CA

8d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Position Overview: The Senior Manager, Field Corrective Actions is responsible for leading and managing all aspects of field corrective actions (FCAs) related to Medtronic Diabetes products. This role ensures compliance with global regulatory requirements, drives cross-functional collaboration, and oversees the timely execution of field actions to protect patient safety and maintain regulatory compliance. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Requirements

• Bachelor’s degree in engineering, Life Sciences, or related field with 7+ years of experience in medical device or related regulated industry, with at least 5 years in a leadership/management role OR master’s degree in engineering, Life Sciences, or related field with 5+ years' experience in medical device or related regulated industry, with at least 5 years in a leadership/management role

Nice To Haves

• Experience leading Field Corrective Actions / Recalls
• Expert knowledge of global regulatory requirements (e.g., FDA 21 CFR 806, EU MDR) for field actions/recalls
• Strong project management and organizational skills
• Strong analytical, problem solving and decision-making skills
• Excellent written/verbal communication and stakeholder management abilities.
• Experience leading cross-functional teams
• Strong experience working with FDA, EU, and other global regulatory bodies
• Strong experience implementing or managing digital solutions for FCA management
• Change management and process improvement experience
• Excellent verbal, written and presentation communication skills

Responsibilities

• Lead the end-to-end process for planning, coordinating, and executing field corrective actions (FCAs), including recalls, notifications, and advisory notices
• Serve as the subject matter expert and primary point of contact for internal and external stakeholders regarding FCAs
• Serve as a regulatory expert, interpreting and applying complex requirements from agencies (FDA, EU MDR, Health Canada, TGA, etc.), and guiding teams through evolving regulations
• Partner with cross-functional teams (Regulatory, Quality, Medical Safety, Operations, Legal, Marketing, Countries/Regions) to assess, develop, and implement effective field action strategies.
• Prepare and submit regulatory filings and communications related to field actions.
• Monitor and report on the progress and effectiveness of field corrective actions
• Utilized advanced technology/digital tools to enhance FCA processes and ensure data integrity, traceability and drive continuous improvement
• Lead, coach, and develop team members; train stakeholders on FCA requirements and best practices
• Support internal/external audits and inspections related to field actions

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees