Experience communicating directly with regulators.
Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization
Proven ability to develop and execute on robust regulatory strategies.
Strong experience reviewing promotional materials for US/EU markets.
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.
U.S. Work Authorization & Sponsorship
Benefits
Health insuranceRemote work optionsEquity / stock options
Additional Information
We anticipate the application window for this opening will close on - 15 Jun 2026
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
This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group.
The Associate Regulatory Affairs Specialist (RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ pulse oximetry monitoring and digital solutions HealthCast™ remote patient monitoring product portfolios within the Acute Care and Monitoring operation unit. This is an ideal opportunity for someone early in their career who is excited to learn, collaborate, and build a strong foundation in regulatory affairs within a highly technical, fast-paced environment.
As an Associate Regulatory Affairs Specialist, you'll support regulatory strategy and execution for these complex, highly engineered products-partnering closely with R&D, Quality, Marketing, and other cross-functional teams throughout the product lifecycle. You'll gain exposure to how products move from early design concepts through regulatory submission and commercialization, helping ensure compliance while enabling innovation.
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 path to market.
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.
Reviews promotional material.
Must Have: Minimum Requirements
Bachelor's degree required
Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
Medtronic · Lafayette, CO