Regulatory Specialist Jobs

About The Position

Requirements

• Bachelor's degree and at least 4 years of regulatory affairs, quality, standards, or medical device experience, or an advanced degree and at least 2 years of such experience.
• Experience managing projects, processes, or initiatives involving multiple stakeholders, products, or regulatory systems.
• Experience coordinating standards assessments and driving actions to completion with Regulatory Affairs and cross-functional subject-matter experts.
• Experience evaluating regulatory impacts and maintaining compliance-related documentation, data, or business processes.
• Experience working in a regulated medical device environment.
• For a baccalaureate degree earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Experience with UDI, global device registrations, EUDAMED, regulatory information management systems, or data governance.
• Experience supporting digital transformation, automation, analytics, or AI-enabled initiatives in a regulated environment.
• Experience assessing regulatory impacts of standards updates across product portfolios and supporting related change assessments.
• Experience leading cross-functional projects involving regulatory systems, process improvements, or enterprise initiatives.
• Knowledge of global medical device regulatory requirements, registrations, and product lifecycle management processes.

Responsibilities

• Serve as a subject-matter expert for regulatory data, related business processes, and regulatory systems across the Neurovascular portfolio.
• Manage regulatory data governance activities, including data quality reviews, discrepancy resolution, remediation, and continuous improvement.
• Coordinate Unique Device Identification (UDI) activities with Regulatory Affairs, Labeling, and cross-functional teams to maintain accurate device registration data.
• Lead standards gap assessments, including assignment, tracking, documentation, stakeholder coordination, and completion of required actions.
• Coordinate regulatory change assessments and evaluate potential impacts across products, regions, registrations, and regulatory systems.
• Lead or support cross-functional regulatory projects involving multiple products, product families, or regulatory teams.
• Support implementation, testing, validation, migration, reconciliation, and verification activities for regulatory systems and digital solutions.
• Partner with business and corporate stakeholders on process improvements, automation opportunities, and AI-enabled regulatory initiatives.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance or reimbursement.
• Global well-being program (Simple Steps).
• 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, subject to IRS earning minimums.
• Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.