Associate Regulatory Affairs Specialist at Medtronic in Lafayette, Colorado

Job Description:

We anticipate the application window for this opening will close on - 22 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
In this role, you will serve as a key coordinator between external partners and internal teams, ensuring the smooth flow of regulatory documentation and compliance-related requests. As a central point of contact, you'll manage the portal and track the progress of requests, such as declarations of conformity or specific manufacturing documents, often liaising with different departments to ensure the right teams are engaged for execution. This role requires a high level of organization, attention to detail, and the ability to collaborate effectively with both internal teams and external partners.

Location: Lafayette, CO

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

• Review and continually manage incoming requests to closure and prioritize needs from the portal


• Monitor and update the status of requests in the internal portal, ensuring all relevant information is accurately logged.


• Communicate with external organizations to confirm submission of required documents and clarify any missing or incomplete information.


• Reach out to the appropriate internal departments (e.g., regulatory, legal, manufacturing) to ensure they have the necessary documentation or understand the next steps.


• Follow up on outstanding requests to ensure timely delivery of documentation, keeping all stakeholders informed on status.


• Address any bottlenecks in the process by identifying the right point of contact or escalating issues when necessary.


• Regularly update tracking systems and databases to reflect the most current information regarding requests and documents.


• 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.

Required Knowledge and Experience:

• Bachelor's degree with 0 years of experience

Nice to Have

• Prior experience in coordinating regulatory processes, managing compliance documentation, or supporting regulatory/clinical teams in administrative roles


• Familiarity with regulatory requirements in the medical device industry


• Ability to manage multiple requests and stakeholders simultaneously, ensuring deadlines are met and that all parties are kept informed.


• Excellent written and verbal communication skills for effectively collaborating with external partners and internal teams. Ability to convey complex requests in simple, clear terms.


• Comfort with navigating and troubleshooting online portals, databases, or other digital tools used for managing requests and documentation.

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):$56,800.00 - $85,200.00

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.