Sr Regulatory Affairs Spec - Neuromod

Medtronic•Minneapolis, MN

7d•$92,000 - $138,000•Onsite

About The Position

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 SENIOR 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 Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU. Role Overview The Senior 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 and obtaining approval for FDA and EU submissions with multiple classification products that range from Class I to Class III in both regulatory environments. Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations Supporting regulatory strategy and submissions for software-driven and cybersecurity-impacting medical devices where applicable 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 significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. 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 directly with FDA and international regulatory agencies on most projects/products at reviewer level, with significant issues reviewed with the manager. Provide regulatory guidance related to software, digital health, and cybersecurity considerations where applicable. To Be Successful in This Role Medical Device Experience: Direct experience in the medical device industry, particularly with Class III medical devices (PMA), including familiarity supporting software-containing or cybersecurity-relevant devices. Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies. Knowledge of Regulatory Requirements: In-depth understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. Software & Cybersecurity Awareness: Working knowledge of regulatory expectations related to software in medical devices and cybersecurity (e.g., FDA software guidance, premarket cybersecurity guidance) is strongly preferred. Strong Communication Skills: Excellent negotiation, 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 and under general direction only. 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 4 years of relevant experience, or an advanced degree with 2 years of experience. About Medtronic 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

Requirements

Medical Device Experience: Direct experience in the medical device industry, particularly with Class III medical devices (PMA), including familiarity supporting software-containing or cybersecurity-relevant devices.
Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies.
Knowledge of Regulatory Requirements: In-depth understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
Software & Cybersecurity Awareness: Working knowledge of regulatory expectations related to software in medical devices and cybersecurity (e.g., FDA software guidance, premarket cybersecurity guidance) is strongly preferred.
Strong Communication Skills: Excellent negotiation, 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 and under general direction only.
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 4 years of relevant experience, or an advanced degree with 2 years of experience.

Nice To Haves

5–8 years of industry experience, with at least 2–3 years in regulatory, clinical, or quality roles.
Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).
Experience working in a regulated biotechnology environment, including extensive involvement with regulatory submissions and interactions with regulatory agencies.
History of successful device submissions.
Experience supporting regulatory strategy or submissions for software-based medical devices and/or devices with cybersecurity considerations strongly preferred.

Responsibilities

Providing expert advice on regulatory requirements
Preparing and obtaining approval for FDA and EU submissions with multiple classification products that range from Class I to Class III in both regulatory environments.
Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations
Supporting regulatory strategy and submissions for software-driven and cybersecurity-impacting medical devices where applicable
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 significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed.
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 directly with FDA and international regulatory agencies on most projects/products at reviewer level, with significant issues reviewed with the manager.
Provide regulatory guidance related to software, digital health, and cybersecurity considerations where applicable.

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.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.
The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.
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, and Simple 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), and Capital 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.