We anticipate the application window for this opening will close on - 31 Jul 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: Strong preference to have candidates work hybrid from Boulder, CO or Minneapolis, MN. Remote within the U.S. may be considered for the right candidate.

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

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties .
Makes improvements of processes, systems or products to enha