Senior Regulatory Affairs Specialist at Medtronic in Lafayette, Colorado

Job Description:

We anticipate the application window for this opening will close on - 29 Nov 2024

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

A Day in the Life
We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM). In this role you will play a key role in the lifecycle management of OEM products. You will be responsible for modifying existing products, preparing and submitting regulatory filings for the U.S. market and managing EU MDR compliance for the European market. You will collaborate closely with our regional and international teams, working with OEM partners to support the submission process and ensure regulatory requirements are met.

Location: Very strong preference to have candidates working hybrid from Lafayette, CO. Could consider remote from the U.S. for the right candidate.

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 or compiles all materials required in submissions, license renewal and annual registrations.


• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.


• Monitors and improves tracking / control systems.


• Keeps abreast of regulatory procedures and changes.


• May direct interaction with regulatory agencies on defined matters.


• Recommends strategies for earliest possible approvals of clinical trials applications.


• Additional tasks as assigned

Required Knowledge and Experience:

• Bachelor's degree with 4+ years of experience in regulatory affairs

• An advanced degree with 2+ years of experience in regulatory affairs

Nice to Have

• 4+ years of medical device regulatory affairs experience


• Local to CO and willing to work hybrid for this role


• Experience with global regulatory pathways such as 510(k) and EU MDR


• Background or coursework in quality systems, including familiarity with ISO standards (e.g., ISO 13485), and experience with Quality Management Systems (QMS)

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):$88,800.00 - $133,200.00

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).

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 90,000+ 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.

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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.