Senior Manager, Regulatory Operations and Transformation
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.
A Day in the Life
The Senior Manager, Regulatory Operations and Transformation is responsible for managing the operational infrastructure, regulatory compliance programs, and product labeling capabilities that enable a high-performing RA organization. This leader supports continuous improvement and operational advancement across the RA function, and the sustained compliance to global regulatory requirements and management of IFUs within the Acute Care & Monitoring (ACM) product portfolio.This is an Onsite role located at our Lafayette, CO campus.
As a member of the RA leadership team, this role collaborates closely withthe network of RAleadersalong with cross-functional team members across the operating unit to ensure RA is equipped with the tools, processes, and systems needed to executeeffectively throughoutthe full product lifecycle.
The Senior Manager leads a multidisciplinary team grounded in accountability, collaboration, operational excellence, and continuous improvement.
RA Operations
Representsthe ACM RA Function for RA Initiativesacross the Enterprise.
Create and execute against a roadmap for RAthat shows the systems, process, and operational improvements for the function.
Lead continuous improvement efforts to reduce redundant manual work across RA by using validated data, building tools that automate repeatable processes, and eliminatingunnecessary work.
Establish and maintainoperational metrics, dashboards, and performance measures that provide visibility into organizational effectiveness forRAoperations and technical communications.
Drive adoption of best practices and operational standards across the organizationfor processes and tools that support regulatory work across the product lifecycle.
Regulatory Compliance
Stays abreast of worldwide regulations and standards and communicates potential risks and mitigation strategies to stakeholders.
Clearly reporttimelines, milestones, and risks toproductcompliance programs that areactioned by a cross functional team.
Oversee the medical device data management for globalUnique Device Identifier(UDI) databaseimplementation programs (includingEUDAMED).
Oversee internal audit readiness,Notified Bodysurveillanceactivity,inspection support activities, compliance monitoring, and corrective action follow-up for RA-related work.
Act as a point of contact forNotified Bodyinteraction including the submissions, deficiency responses, and certificate management.
Technical Communications
Provideoperational direction for Technical Communications teams responsible for product labeling and documentation.
Act as a steward of technical communications and oversee development, translation, and delivery of IFUsfor all products within the ACM portfolio.
Drive continuous improvement in documentation practices, tools, workflows, and content management processes, including hyperautomationinitiatives.
Drive thetransition to eIFUacross the ACM portfolio.
Own UDI administration, including GS1 GTIN issuance and hierarchy management.
Team & Resource Management
Manages and developsdiverse teamsof program managers,RA specialists,and technical communications leads.
Assess resource requirements based on business prioritiesand needs and allocatesresources as requiredto meet those objectives. Able to align capabilitiesto project work as it evolves over time.
Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
Create an environment that promotes clear communication(verbal and written), accountability, engagement, innovation, and continuous learning.
Required Qualifications:
Bachelor's degree in Science, Engineering, Business Administration, orrelateddiscipline.
Minimum of 7years of experiencecombinedin regulatory operations with 5+ years of managerial experience.
Demonstrated experience leading operational improvement initiatives within a complex, matrixed, and highly regulated environment.
Experience implementing digital solutionsand software, automation initiatives, and workflow optimization efforts.
Preferred Qualifications:
Strong knowledge of global regulatory requirements and quality systems.
Experience leading product labeling,publishing, content development, and/or documentation teams.
Knowledge of monitoring and/or diagnostic medical devices preferred.
Experience prioritizing work, leading and empowering team members, and driving tasks to completion.
Demonstrated success building and leading high-performing teams.
Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
Strong business orientation - ability to communicate and interact effectively with senior business leaders.
Strong background in project management with demonstrated success at bringprojects to completion on time.
Ability to inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
Demonstrate leadership courage through bold thinking and change management.
Ability to attract, recruit, mentor, and retainhigh-caliber professionals
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.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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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):$154,400.00 - $231,600.00This 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, 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 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), 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 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.