Associate Regulatory Affairs Specialist

Medtronic • Plymouth, MN

5d • $60,000 - $90,000 • 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 The Peripheral Vascular Health operating unit focuses on diagnosing and treating diseases of the peripheral arteries and veins, helping patients restore blood flow and reduce the risk of limb loss and other serious complications. The portfolio includes minimally invasive technologies such as drug-coated balloons, stents, atherectomy, thrombectomy, and embolic protection, designed to address complex peripheral vascular disease across a range of patient anatomies. By combining innovation, clinical evidence, and physician partnership, the operating unit aims to improve procedural outcomes and quality of life for patients worldwide. 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. This position will be based in Plymouth, MN. The Associate Regulatory Affairs (RA) Specialist will plan and execute global regulatory activities (e.g. submissions, STED/GSSD updates, change assessments) necessary to obtain and maintain regulatory approvals within International markets. This position ensures compliance with required global regulations and Medtronic policies for peripheral vascular products and serves as a key team member and/or in a lead role on extended team(s).

Requirements

• Bachelors Degree
• 0 years of experience required
• 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

• Medical device or regulatory experience
• Previous experience working across geographies/countries
• Strong Interpersonal and analytical skills
• Strong communication skills
• Attention to detail
• Strong Technical Writing Skills

Responsibilities

• Provide support to the Geography RA who interact with regulatory authorities to assure timely new product introductions and continued product access
• Work on cross-functional teams, providing inputs to international regulatory strategy and execution
• Assist in keeping company informed of regulatory requirements in international markets
• Provides regulatory review of labeling, design changes, and specification changes as it relates to specific geographies
• Work with Geography RA teams to develop International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing
• Author Product Summary Technical Documentation (STED) or Global Submission Strategy Documentation.
• Supports Geography RA team to prepare international submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements
• Ensures relevant FDA and international import/export requirements are met, as required
• Supports international product demand planning and release activities
• Reviews Change Orders and assess regulatory impact of product changes on international regulatory strategy and submissions per standard procedures
• Supports post market regulatory compliance activities for international product approvals
• Develops and maintains regulatory affairs department procedures and process improvements
• Other duties as assigned or required

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values.
• We recognize their contributions.
• They share in the success they help to create.
• 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 , and 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) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
• Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees