Principal Regulatory Affairs Specialist - Onsite

Medtronic•Minneapolis, MN

1d•$120,000 - $180,000•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 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 provides advanced therapies for chronic pain, movement disorders, and other neurological conditions. Through spinal cord stimulation, deep brain stimulation, and targeted drug delivery systems, we deliver personalized treatments that restore function, reduce symptoms, and improve quality of life worldwide. The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for developing Class II and Class III medical device regulatory strategies and preparing US and worldwide product submissions to introduce products and changes to the market. The Pr. RAS also supports marketed product activities, including the development of advertising and promotional materials, license maintenance, annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

Bachelor’s degree in life science, engineering, or a related field
Minimum 7 years of relevant experience, or an advanced degree with 5+ years of experience

Nice To Haves

7-10 years of industry experience, with at least 4-5+ 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 involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, EU Notified Body), and working with cross-functional project teams.
In-depth experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive (AIMDD)/EU Medical Device Regulation (MDR), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Experience with Class II medical devices (510(k))
Experience with Class III medical devices (PMA)
History of successful device submissions
Strong negotiation skills and written/oral communication skills
Strong organizational and time management skills
Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Computer skills: MS Office, MS Project, Adobe Acrobat, and Agile
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

Prepare and support US, EU, and Canadian submissions and reviews, and support international submission reviews for new products and product changes to ensure timely market release approvals.
Interact directly with FDA and/or indirectly with international regulatory agencies on most projects at the reviewer level and resolve submission issues with internal cross-functional team members, Medtronic geography regulatory partners, and regulatory agencies as needed.
Lead and execute regulatory strategies/plans and provide regulatory compliance requirements in support of cross-functional product development and product change teams.
Find, interpret, and apply regulations and guidance appropriately for situations.
Provide regulatory support for currently marketed products. This includes reviewing changes to existing devices, labeling, and other documentation.
Prepare submissions and reports for regulatory agencies, as required.
Collaborate with Marketing and Medical Education teams to develop and maintain advertising, promotion, and educational materials.
Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, product recalls, etc., as needed.
Review significant regulatory issues with supervisor, as necessary, and work under general supervision following established procedures.
Independently develop and determine a regulatory approach.
Keep current on global directives, harmonized standards, and procedures, and communicate changes that may affect cross-functional areas.
Ensure personal understanding of all quality policy/system items that are personally applicable.
Follow all work/quality procedures to ensure compliance with the quality system and high-quality work.
Provide training and support for other members of the department.
May mentor or supervise other RAS, as directed by the manager.
Other tasks, as required.

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)