We anticipate the application window for this opening will close on - 14 Aug 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

Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD and MDR Regulation. Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

• Prepare Technical Files /Design Dossier, Change Notifications, Submissions (e.g. Documentary Audits under MDD/ MDR)

• Creates, reviews and approves engineering change requests.

• Assist with defining the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.

• Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.

• Prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.

• Reviews protocols and reports to support regulatory submissions.

• Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring agency approval.

• Interact directly with Notified Bodies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.

• Maintain proficiency in global regulatory requirements; establish and maintain good relationships with agency personnel.

• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products.

• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

• Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures.

• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

• Assist with negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.

• Provide regulatory input to product lifecycle planning.

• Provide feedback and on-going support to product development teams for regulatory issues and questions.

• Ensure personal understanding of all quality policy/system items that are personally applicable.

• Follow all work/quality procedures to ensure quality system compliance and high-quality work

• Acts as liaison between the Company and the various regulatory agencies. Interfaces directly Notified Bodies

• Other duties as assigned. Include a brief business and/or portfolio description, and/or include a link to product portfolio as applicable

Must Have: Minimum Requirements (Standard minimum requirements automatically uploaded from Workday)

To be considered for this role, please ensure the minimum requireme