Sr Regulatory Affairs Spec - Neuromod

Medtronic•Minneapolis, MN

10d•$92,000 - $138,000•Onsite

About The Position

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. A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST Onsite 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 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 Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU. Role Overview 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 and obtaining approval for FDA and EU submissions with multiple classification products that range from Class I to Class III in both regulatory environments. Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations Supporting regulatory strategy and submissions for software-driven and cybersecurity-impacting medical devices where applicable A Day In The Life 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. Provide regulatory guidance related to software, digital health, and cybersecurity considerations where applicable. To Be Successful in This Role Medical Device Experience: Direct experience in the medical device industry, particularly with Class III medical devices (PMA), including familiarity supporting software-containing or cybersecurity-relevant devices. 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. Software & Cybersecurity Awareness: Working knowledge of regulatory expectations related to software in medical devices and cybersecurity (e.g., FDA software guidance, premarket cybersecurity guidance) is strongly preferred. 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.

Requirements

Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.
Direct experience in the medical device industry, particularly with Class III medical devices (PMA), including familiarity supporting software-containing or cybersecurity-relevant devices.
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.
Working knowledge of regulatory expectations related to software in medical devices and cybersecurity (e.g., FDA software guidance, premarket cybersecurity guidance) is strongly preferred.
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.

Nice To Haves

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.
Experience supporting regulatory strategy or submissions for software-based medical devices and/or devices with cybersecurity considerations strongly preferred.
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 and obtaining approval for FDA and EU submissions with multiple classification products that range from Class I to Class III in both regulatory environments.
Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations
Supporting regulatory strategy and submissions for software-driven and cybersecurity-impacting medical devices where applicable
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.
Provide regulatory guidance related to software, digital health, and cybersecurity considerations where applicable.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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).