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Sr. Manager, Field Corrective Actions

Sr. Manager, Field Corrective Actions

Medtronic PlcLos Angeles, CA, US
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Senior Manager, Field Corrective Actions

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.

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.

Key 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
  • Ensure compliance with applicable regulatory requirements (e.g., FDA, EU MDR, Health Canada, etc.)
  • 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
  • Leverage 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

Minimum 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 Have

  • Demonstrated 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
  • Experience working with FDA, EU, and other global regulatory bodies
  • Experience implementing or managing digital solutions for FCA management
  • Change management and process improvement experience
  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

    Benefits & Compensation

    Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

    Salary ranges for U.S (excl. PR) locations (USD) : $168,800.00 - $253,200.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification / education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others)

    The following benefits and additional compensation are available to those regular employees who work 20+ hours per week : 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, and Simple Steps (global well-being program).

    The following benefits and additional compensation are available to all regular employees : 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

    Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

    Further details are available at the link below :

    About Medtronic

    We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

    Learn more about our business, mission, and our commitment to diversity here.

    It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

    If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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