Regulatory Affairs Specialist -Neuro

Medtronic•Minneapolis, MN

13d•Onsite

About The Position

We anticipate the application window for this opening will close on - 24 Mar 2026 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 REGULATORY AFFAIRS SPECIALIST Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Regulatory Affairs Specialist who has experience supporting regulatory submissions for both the Americas and the EU. Role Overview The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to market. This role involves: Providing expert advice on regulatory requirements Preparing submissions Supporting approval activities Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations A Day In The Life Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review regulatory issues with the manager as necessary and support resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls. Provide regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation. Provide feedback and ongoing support to product development teams for regulatory issues and questions. Interact with FDA and international regulatory agencies on assigned projects/products, with significant issues reviewed with the manager. To Be Successful in This Role Medical Device Experience: Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA). Regulatory Submission Expertise: Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies. Knowledge of Regulatory Requirements: Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. Strong Communication Skills: Strong written and oral communication skills to effectively interact with regulatory agencies and cross-functional teams. Organizational Skills: Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines. Independence and Initiative: Ability to work independently under general direction. Computer Skills: Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile. Must Have: Minimum Requirements Bachelor’s degree in a scientific discipline or equivalent with 2 years of relevant experience , or an advanced degree with 0 years of experience . Nice To Have 2–5 years of industry experience, with at least 2–5 years in regulatory, clinical, or quality roles. Advanced degree in scientific discipline (engineering, physical/biological, or health sciences). Experience working in a regulated biotechnology or medical device environment. Exposure to device submissions and interactions with regulatory agencies. 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. 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 section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

Requirements

Medical Device Experience: Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA).
Regulatory Submission Expertise: Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies.
Knowledge of Regulatory Requirements: Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
Strong Communication Skills: Strong written and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.
Organizational Skills: Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
Independence and Initiative: Ability to work independently under general direction.
Computer Skills: Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile.
Must Have: Minimum Requirements Bachelor’s degree in a scientific discipline or equivalent with 2 years of relevant experience , or an advanced degree with 0 years of experience .
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.

Nice To Haves

2–5 years of industry experience, with at least 2–5 years in regulatory, clinical, or quality roles.
Advanced degree in scientific discipline (engineering, physical/biological, or health sciences).
Experience working in a regulated biotechnology or medical device environment.
Exposure to device submissions and interactions with regulatory agencies.

Responsibilities

Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release.
Review regulatory issues with the manager as necessary and support resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies.
Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.
Provide regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.
Provide feedback and ongoing support to product development teams for regulatory issues and questions.
Interact with FDA and international regulatory agencies on assigned projects/products, with significant issues reviewed with the manager.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values.
We recognize their contributions.
They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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).