Medtronic · 4 months ago
Sr. Manager, Recalls/Field Corrective Actions
Medtronic is a leader in global healthcare technology, and they are seeking a Senior Manager for Field Corrective Actions to oversee all aspects of recalls and field actions related to their Diabetes products. This role involves ensuring compliance with regulatory requirements, driving collaboration across teams, and protecting patient safety through effective field action strategies.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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
Qualification
Preferred
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
Benefits
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Recent News
2026-01-13
2026-01-13
Company data provided by crunchbase