Customer Quality Regulatory Inquiry Manager

We anticipate the application window for this opening will close on - 14 Sep 2026

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 95000 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 -person exchanges are invaluable to our work. Were 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 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 Bachelors 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 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 @ 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 .

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):$113600.00 - $170400.00

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 85520.00 EUR- 128280.00 EUR

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 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 findhere 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.