Senior Regulatory Affairs Spec

We anticipate the application window for this opening will close on 31 Aug 2026.

About the role

We are looking for a passionate Senior Regulatory Affairs Specialist in our Cardiac Ablation Solutions Operating Unit to work primarily on software-based medical devices. The candidate must have successful experience authoring and clearance of software submissions using FDA's eStar program as well as submissions to the EU Notified Body. A deep understanding of software engineering standard IEC 62304 and experience with software lifecycle process is also key.

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. This position will be based in Mounds View, MN.

Responsibilities

• Prepare US and EU MDR submissions for new products and their product changes as required to ensure timely approval for market release.
• Review significant regulatory issues with Manager, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
• Prepare regulatory strategies/plans and 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.
• Negotiate with international agencies, as needed.
• 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.
• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Keep current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
• Provide training and support to other members of the department.
• Other tasks, as required.

Requirements

• 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Skills

• Complete understanding and wide application of technical or regulatory principles, theories and concepts.
• General knowledge of other related disciplines.
• In depth experience with FDA requirements, FDA guidance documents, EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
• Working knowledge of SaMD and SiMD.
• Positive track record engaging with regulators.
• History of successful device submissions.
• Strong negotiation skills and written/oral communication skills.
• Strong organizational skills and time management skills.
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines.
• Ability to work independently and under general direction only.
• Computer skills: MS Office, MS Project, Adobe Acrobat and Agile.

Nice to Have

• Master of Science Degree.
• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams.

Benefits

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• Health, Dental and vision insurance.
• Health Savings Account, Healthcare Flexible Spending Account.
• Life insurance, Long-term disability leave.
• Dependent daycare spending account, Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match.
• Short-term disability, Paid time off, Paid holidays.
• Employee Stock Purchase Plan, Employee Assistance Program.
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

The following benefits and additional compensation are available to all regular employees:

• Medtronic Incentive Plan (MIP).

Please note some of the above benefits may not apply to workers in Puerto Rico.

Pay

Salary ranges for U.S (excl. PR) locations (USD): $92,000.00 - $138,000.00.

Schedule

This position requires working a minimum of 4 days a week onsite in Mounds View, MN.