Regulatory Affairs Specialist

Medtronic•Minneapolis, MN

2d•$74,400 - $111,600•Onsite

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.

Requirements

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.
Bachelor’s degree in a scientific discipline or equivalent
Minimum 2 years of regulatory affairs 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

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.

Responsibilities

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 market release approvals.
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.