Medtronic
MEDICAL DEVICES
Medical Devices
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Customer Quality Regulatory Inquiry Manager
Medtronic
This listing was originally posted on Medtronic's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
The Customer Quality Regulatory Inquiry Manager will lead a team responsible for coordinating and delivering timely, accurate, and well-supported responses to global regulatory authority inquiries related to post-market quality activities. Inquiries may include matters associated with complaint handling, regulatory reporting, field corrective actions, and other post-market quality processes.
This role will establish and mature the operating model for a newly consolidated team, ensuring effective intake, prioritization, assignment, escalation, review, and tracking of regulatory inquiries. The manager will lead a team of approximately seven professionals and will be accountable for building team capability, driving role clarity, strengthening execution discipline, and improving timeliness and quality of regulatory responses.
The role requires strong knowledge of medical device post-market quality systems and the ability to lead cross-functional collaboration with Regulatory Affairs, Legal, Quality, and business-unit subject-matter experts. The manager will communicate performance, risks, trends, and improvement priorities to senior and executive leadership.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role has the potential of 10% travel.
Primary Responsibilities:
Directly Manage Professionals, including but not limited to:
Goal setting,
Establishing measurable performance expectations,
Assigning and balancing work,
Assessing employee leveling,
Conducting Performance Reviews,
On-going assessment, and response when needed for personnel management through coaching, improvement plans, etc.
Establish, implement, and continuously improve a standardized end-to-end operating model for regulatory inquiries, including intake, risk-based prioritization, assignment, response development, review, approval, submission, escalation, and closure
Drive operational performance through the development and use of meaningful metrics, dashboards, and reporting mechanisms, including inquiry volume, aging, on-time response performance, cycle time, response quality, workload capacity, and recurring inquiry trends.
Own and evaluate existing processes; and plan and implement process improvement initiatives.
Organize, lead and facilitate cross-functional teams and team meetings.
Communicate team progress, including executive leader communication, and presentations.
Required Qualifications:
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Requires a Bachelor’s degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of prior relevant experience.
Preferred Qualifications:
Requires a minimum of 2 years of prior experience supervising or managing others and experience managing new or growing teams.
Knowledge of FDA, EU MDR, and other global regulatory requirements.
Relevant experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling, regulatory reporting, field corrective actions, or related regulated healthcare or life-sciences environment.
Demonstrated experience leading cross-functional work in a regulated environment.
Demonstrated experience managing complex work to defined timelines, including issue escalation and stakeholder coordination.
Strong written communication skills, including the ability to develop clear, concise, and evidence-based technical or regulatory communications.
Strong verbal communication, presentation, and stakeholder-management skills.
Knowledge of Lean Six Sigma Black Belt or similar methodologies to drive continuous improvement.
Ability to executive-level presentations and communicate complex topics effectively.
Experience Implementing process automation, workflow optimization, and technology solutions.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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 your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
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.
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:
Medtronic benefits and compensation plans
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 here 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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MEDICAL DEVICES
Medical Devices
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