Regulatory Affairs Specialist -Neuro
About The Position
Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. 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. 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 seeking a passionate Regulatory Affairs Specialist with experience supporting regulatory submissions across the Americas and the EU. 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 the market.
Requirements
- Minimum Requirements Bachelor’s degree in a scientific discipline or equivalent
- Minimum 2 years of regulatory affairs experience
- 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.
Nice To Haves
- Experience in regulatory affairs, including conducting change assessments for Class II (510(k) devices).
- Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).
- 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.
Responsibilities
- 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
- 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 the 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.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
