We anticipate the application window for this opening will close on - 23 Jun 2025

 

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 Medtronic products that get integrated with our strategic partners. You will be responsible for engaging with strategic partners in integration projects, preparing and submitting regulatory filings for the U.S. and EU market and managing global compliance. You will collaborate closely with engineering, marketing, clinical, quality as well as the regional and international teams working with integration partners to support the submission process and ensure regulatory requirements are met.

Location: This is a hybrid role and we will not consider candidates to work remotely. The team has a strong preference for candidates to work hybrid from Lafayette, CO but will also consider candidates to work hybrid from Mounds View, MN / Mansfield, MA

Responsibilities may include the following and other duties may be assigned

• Participate in negotiations and interactions with regulatory authorities during the development and review process
• Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team
• Support international product registrations as needed
• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
• Review promotional and advertising material
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits as needed
• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
• 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

OR

• 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
• Knowledge of FDA and EU MDR requirements
• Experience of working with all classification of product in the U.S and/or EU.
• Background or coursework in quality systems, including familiarity with ISO standards (e.g., ISO 13485), and experience with Quality Management Systems (QMS)
• Technical Writing
• International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR)
• Product Labeling requirements and standards
• May have practical knowledge of project management
• Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems
• Experience working with OEMs or strategic partners
• Experience working on integrations

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