Sr Regulatory Affairs Spec -Neuro

We anticipate the application window for this opening will close on - 9 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.

Location:

Onsite (4 days a week)

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 submissions
• Negotiating 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/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.

Direct experience submitting regulatory submissions for both the Americas and the EU.

• Medical Device
  
  Experience:
  
  Direct experience in the medical device industry, particularly with Class III medical devices (PMA).
• 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.
• 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.

• Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.

• 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.
• Cybersecurity / Software experience (strong plus).

Competitive salary range: $92,000 – $138,000 USD (U.S. locations). Eligible for the Medtronic Incentive Plan (MIP) and various benefits including health, dental, vision, HSA, retirement, stock purchase, paid time off, and more.

Medtronic provides 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. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.