Senior Manager, Regulatory Operations and Excellence

COV Covidien LP; United States; On-site; USD 154,000 - 232,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Paid time off

Tuition assistance/reimbursement

Employee stock purchase plan

Employee assistance program

Job summary

Medtronic in Lafayette, Colorado is seeking a Senior Manager of Regulatory Operations and Excellence to lead a multidisciplinary team across Regulatory Operations, Compliance, and Technical Communications. You will drive a strategic roadmap, advance automation, and ensure global regulatory success for ACM products.

The role requires a bachelor’s in a technical field, 7+ years in regulatory operations and at least 5 years in people leadership within a regulated environment.

Qualifications

• Bachelor’s degree in science, engineering, business administration or related technical field with 7+ years in regulatory operations or regulatory affairs.
• Minimum 5+ years in people leadership within a matrixed, regulated environment.
• Experience delivering digital solutions, automation, and workflow optimization in regulatory contexts.
• Experience establishing governance, metrics, and cross-functional program reporting.

Responsibilities

• Lead Regulatory Operations, Regulatory Compliance, and Technical Communications teams for the ACM portfolio.
• Develop and execute a roadmap for regulatory systems, processes, tools, and capabilities.
• Drive operational excellence by simplifying workflows and implementing automation.
• Establish metrics, dashboards, and governance for regulatory performance and compliance.
• Oversee global compliance programs including UDI, EUDAMED, audits, and inspection support.
• Provide leadership for product labeling and technical communications including IFU translation and publication.
• Collaborate with leaders to communicate timelines, risks, and requirements across the lifecycle.
• Coach and develop a team of program managers and regulatory professionals.

Skills

Regulatory operations

Regulatory affairs

Operational excellence

Cross-functional leadership

Process automation

Regulatory systems

Governance processes

Education

Bachelor's degree in Science/ Engineering/ Business Administration or related

Job description

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 Acute Care & Monitoring (ACM) Regulatory Affairs (RA) organization supports a global portfolio of monitoring, diagnostic, and patient care technologies used across the continuum of care. The function is responsible for enabling regulatory compliance, operational excellence, and product lifecycle support through the development of scalable processes, systems, and governance frameworks that support regulatory activities worldwide. This role is part of the ACM Regulatory Affairs leadership team and provides leadership across Regulatory Operations, Regulatory Compliance, and Technical Communications. The position oversees critical capabilities including regulatory systems and processes, global compliance programs, Unique Device Identification (UDI), product labeling, Instructions for Use (IFU) management, and digital transformation initiatives that enable a high-performing regulatory organization.

This is an onsite position based at the Lafayette, Colorado campus.

The Senior Manager, Regulatory Operations and Excellence leads a multidisciplinary team responsible for the operational infrastructure, compliance programs, and technical communication processes that enable regulatory success across the ACM portfolio. This leader partners with Regulatory Affairs and cross‑functional stakeholders to advance operational excellence, drive process automation and digital transformation, maintain global regulatory compliance, and ensure effective development and management of product labeling and documentation throughout the product lifecycle.

Primary Responsibilities

• Lead Regulatory Operations, Regulatory Compliance, and Technical Communications teams supporting the ACM product portfolio.
• Develop and execute a strategic roadmap for regulatory systems, processes, tools, and operational capabilities that improve organizational effectiveness and scalability.
• Drive operational excellence initiatives by simplifying workflows, reducing manual activities, implementing automation solutions, and establishing best practices across the Regulatory Affairs organization.
• Establish and maintain operational metrics, dashboards, and performance measures to provide visibility into regulatory performance, compliance status, and organizational effectiveness.
• Oversee global regulatory compliance programs, including UDI and EUDAMED data management, audit readiness activities, inspection support, corrective action follow‑up, and Notified Body interactions.
• Provide operational leadership for product labeling and technical communications activities, including IFU development, translation, publication, content management, and eIFU implementation.
• Partner with Regulatory Affairs leaders and cross‑functional stakeholders to communicate program timelines, risks, compliance requirements, and operational priorities across the product lifecycle.
• Lead, develop, and coach a team of program managers, regulatory specialists, and technical communications professionals while aligning resources to business priorities and organizational objectives.

Required Qualifications

Bachelor's degree in Science, Engineering, Business Administration, or a related technical discipline and a minimum of 7 years of experience in regulatory operations, regulatory affairs, quality, compliance, or operational excellence with 5+ years of people leadership experience. Experience leading operational improvement initiatives within a complex, matrixed, and highly regulated industry. Experience implementing digital solutions, automation initiatives, workflow optimization programs, or business process transformation projects. Experience establishing operational metrics, performance dashboards, governance processes, or business reporting frameworks. Experience managing cross‑functional programs involving multiple stakeholders, priorities, and global regulatory requirements.

Preferred Qualifications

Knowledge of global medical device regulatory requirements, quality systems, and compliance frameworks. Experience leading product labeling, technical communications, publishing, documentation management, or content development functions. Experience supporting UDI, EUDAMED, GS1 GTIN administration, or global device data management programs. Knowledge of monitoring, diagnostic, or acute care medical device technologies. Demonstrated success building and leading high‑performing teams while driving organizational change and continuous improvement initiatives. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8C.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.

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 - $231,600.00 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).

• Health
• Dental
• Vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long‑term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well‑being program)

• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

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.

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.

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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care.