Senior Regulatory Affairs Specialist - Onsite

Medtronic • Minneapolis, MN

8d • $92,000 - $138,000 • Onsite

About The Position

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 worldwide. 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. 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 the market. This role involves: Providing expert 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. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/theries 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. Partner with geography partners to develop regulatory strategy, submit submissions, or respond to regulators. 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. Support of marketing claim development and review of advertising and promotion materials. Regulatory strategies and support may also include clinical investigations in the US and worldwide. 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 the reviewer level, with significant issues reviewed with the manager.

Requirements

• Direct experience in the medical device industry, particularly with Class III medical devices (PMA).
• Proven experience preparing and 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.
• Bachelor’s degree in a scientific discipline or equivalent.
• Minimum 4 years of relevant experience, or an advanced degree with 2 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

• 5-8 years of industry experience, with at least 2-3 years in regulatory, engineering, clinical, or quality roles.
• Advanced degree and experience 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.
• Engineering or Cybersecurity / Software / AI experience (strong plus).

Responsibilities

• Develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market.
• Provides expert advice on regulatory requirements.
• Prepares submissions.
• Negotiates their approval.
• Assists with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations.
• Teams with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/theries and changes to existing products.
• Collaborates with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Prepares FDA, European, and Canadian submissions for product changes to ensure timely approval for market release.
• Partners with geography partners to develop regulatory strategy, submit submissions, or respond to regulators.
• Reviews significant regulatory issues with the manager as necessary, and resolves submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed.
• Supports regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.
• Provides regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.
• Supports marketing claim development and review of advertising and promotion materials.
• Provides regulatory strategies and support which may include clinical investigations in the US and worldwide.
• Provides feedback and ongoing support to product development teams for regulatory issues and questions.
• Interacts directly with FDA and international regulatory agencies on most projects/products at the reviewer level, with significant issues reviewed with the manager.

Benefits

• 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)

What This Job Offers

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