Regulatory Affairs Specialist -Neuro

Medtronic•Minneapolis, MN

2d•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 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 experience supporting regulatory submissions for both 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 market. This role involves: 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.

Requirements

Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA).
Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies.
Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
Strong 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 under general direction.
Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile.
Bachelor’s degree in a scientific discipline or equivalent with 2 years of relevant experience, or an advanced degree with 0 years of experience.

Nice To Haves

2–5 years of industry experience, with at least 2–5 years in regulatory, clinical, or quality roles.
Advanced degree in scientific discipline (engineering, physical/biological, or health sciences).
Experience working in a regulated biotechnology or medical device environment.
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

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 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)