Regulatory Affairs Specialist

Medtronic • Minneapolis, MN

3d • 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 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 direct experience submitting regulatory submissions for both the Americas and the EU. Role Overview The Regulatory Affairs Specialist helps develop 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 advice on regulatory requirements Preparing submissions Negotiating their approval 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 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. To Be Successful in This Role Medical Device Experience: Direct experience in the medical device industry, particularly with Class III medical devices (PMA). Regulatory Submission Expertise: Proven experience preparing and assisting with 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. 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.

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.
• Direct experience in the medical device industry, particularly with Class III medical devices (PMA).
• Proven experience preparing and assisting with submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies.
• In-depth understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
• Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.
• Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
• Ability to work independently and under general direction only.
• Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile.

Nice To Haves

• 1-2 years of industry experience, with at least 1-2 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.
• Cybersecurity / Software experience (strong plus)

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 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level