We anticipate the application window for this opening will close on - 23 Jan 2026

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

This position is located in Lafayette CO as part of the Acute Care & Monitoring (ACM) group.

The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating planning and executing regulatory activities related to the Bispectral Index (BIS) monitoring product portfolio within the Acute Care and Monitoring operation unit. This role is fit for an established productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general the position you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities requiring awareness of wider organizational issues.
You will recommend and own improvements to systems and processes to enhance effectiveness and regularly communicate with internal stakeholders to share updates gather input and support decision-making. You will function as a subject matter expert within the organization and as an individually contributing leader. As such you serve as a role model and may also guide entry-level professionals or support staff eventually offering direction and assistance when needed.

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
• Leads and compiles all materials required for US and EU submissions and tenders including 510(k) submissions NB sampling and EU MDR Technical Documentation.
• Supports submissions and inquiries for global markets.
• Collaborates closely with cross-functional partners such as R&D clinical operations and marketing to establish regulatory value and ensure regulatory requirements and strategy are integrated into product development and lifecycle management.
• Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
• Reviews promotional material.
• Monitors updates and improves project tracking and US/EU distribution control systems.
• Proactively monitor and interpret evolving global regulatory requirements and communicate potential impact to stakeholders.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible path to market.
• Support internal and external audits/inspections including serving as a functional lead.
• Develop and deliver training on regulatory requirements and changes to cross-functional teams.
• Mentor junior regulatory staff or provide onboarding support.
• Participate in CAPA investigations when regulatory issues are identified.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.

Nice to Have

• Experience in medical device regulatory
• Strong experience with class I and II electrical and software-based devices including applicable standards
• Strong knowledge of EU MDR ISO 10993- 1 13485 ans ISO risk management principles
• Experience with regulatory requirements for cybersecurity AI and communication devices (interoperability)
• Proven experience authoring and leading 510(k) submissions and EU Change Notifications
• Strong experience compiling MDR Technical Documentation.
• Experience communicating directly with regulators
• Collaborative solution-oriented performer focused on bringing value to stakeholders and the organization
• Proven ability to develop and execute robust regulatory strategies
• Strong experience reviewing promotional materials for US/EU markets.

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.

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):$118400.00 - $177600.00

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).

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

About Medtronic

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 95000 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.

Learn more about our business mission and our commitment to diversity here.

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.