We anticipate the application window for this opening will close on - 19 Dec 2025

 

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.

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

- 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

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:

• 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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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 yo