We anticipate the application window for this opening will close on - 18 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

At Medtronic Cardiac Ablation Solutions, our vision is to provide cardiac mapping and ablation solutions that will enable clinicians to treat patients more safely and efficiently, with more predictable procedure times and outcomes.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Cardiac Ablation Solution devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval.  The specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

Role and Responsibilities: 

• Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release.  Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
• Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements.  Provide on-going support to project teams for regulatory issues and questions.  Find, interpret and apply regulations and guidance appropriately for situations.
• Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
• Provide regulatory support for currently marketed products as necessary.  This includes reviewing labeling and changes to existing devices and documentation.  Prepare submissions and reports for regulatory agencies as required.
• Complete understanding and wide application of technical or regulatory principles, theories and concepts.  General knowledge of other related disciplines.
• Negotiate with regulatory agencies, as needed.  All significant issues will be reviewed with the supervisor.
• Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
• Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Cardiac Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Work under general supervision following established procedures. Independently determines and develops approach.
• Frequent inter-organizational contact and some external contacts. 
• Keeps current on global directives, regulations harmonized standards and Medtronic procedures and communicates changes that may affect cross functional areas.
• Provide training and support to other members of the department.
• Other tasks, as required.

Must Have

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile

• Bachelor’s degree in a technical discipline
• Minimum 4 years of medical device regulatory experience with Bachelor’s degree
• Or minimum 2 years of medical device regulatory experience with an advanced degree

Nice To Have

• Experience working in regulated environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, Notified Bodies, NMPA and PMDA etc.), and working with cross-functional project teams.   
• Master of Science Degree
• In depth experience with FDA