Associate Regulatory Affairs Specialist

Overview

The Associate Regulatory Affairs Specialist will work under the guidance of a manager and senior regulatory specialists to support products within the Cardiac Ablation business. The role blends international regulatory affairs, regulatory operations, and project coordination activities. It will be based in Mounds View, MN.

• Understand global regulatory requirements and conduct detailed requirement research.
• Contribute to global product registration maintenance, including EU MDR Technical Documentation and MDD Technical Files.
• Assess device changes for registration implications and electronically notify geographies of regulatory changes.
• Route regulatory documents for approvals in electronic systems, maintain approval information, and manage electronic document collections.
• Support requests to systems related to product release, economic operator verification, registration, and listing.
• Participate in the preparation for internal and external regulatory audits.
• Compile materials required for new global product submissions, license renewals, and change submissions.
• Monitor, maintain, and improve global regulatory tracking/control systems.
• Request, obtain, and maintain FDA Certificate of Foreign Government (CFGs), EC/ISO certificates, and other regulatory documents.
• Keep abreast of regulatory procedures and changes, performing other regulatory duties as needed.

• Bachelor's degree
• 0 years of regulatory affairs or related experience

• Bachelor’s Degree in a health profession, science, and/or engineering field
• Experience in the medical device industry
• Demonstrated technical writing skills
• Strong computer skills, including word processing, Excel and project management tools, manipulating spreadsheets, creating presentations, and using PowerBI tools
• Excellent organizational and project management skills
• Strong written, verbal and interpersonal skills
• Notary license
• For Baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8C.F.R. §214.2(h)(4)(iii)(A)

• Competitive salary range (USD): $60,800.00 – $91,200.00
• Short‑term incentive called the Medtronic Incentive Plan (MIP)
• 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 with employer contribution and match;
  Short‑term disability;
  Paid time off;
  Paid holidays;
  Employee Stock Purchase Plan;
  Employee Assistance Program;
  Non‑qualified Retirement Plan Supplement;
  Capital Accumulation Plan (for select positions)

Medtronic is an equal employment opportunity employer that provides a diverse, inclusive and collaborative environment. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. All persons are equally eligible for employment and the brand of the company reflects its commitment to a bias‑free hiring environment.