Regulatory Affairs Specialist -Neuro
Medtronic
Minneapolis, Minnesota, United States of America
Full-Time
$74,400
OfficeSenior
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.
REGULATORY AFFAIRS SPECIALIST
Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life.
Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions
Pelvic Health
Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life.
Check us out on LinkedIn: Medtronic Pelvic Health
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 at our Minnesota Rice Creek East facility 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
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.
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, andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: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), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findherea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.