We anticipate the application window for this opening will close on - 24 Mar 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

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ Blood Oxygenation Management Franchise within the Acute Care and Monitoring Operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation.

The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. The initial project scope for this employee will be related to regulatory sustaining activities. NPD activities may be tied into the role later on.

Location: Hybrid from Lafayette, CO (strongly preferred) or Minnesota / this role does not have a budget for relocation assistance.

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

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
• Prepare 510(k) submissions and technical documents to support CE mark and other international submissions
• Prepare rationales to file documentation for modifications to devices when appropriate
• 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.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Perform other duties as assigned or required

Required Knowledge and Experience: 

• Bachelors degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry

OR

• An advanced degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry

Nice to Have

• Knowledge of FDA and EU MDR requirements
• Experience of working with all classification of product in the U.S and/or EU.
• Design Dossier and/or Technical Documentation experience
• 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

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 sect