Senior Regulatory Affairs Specialist - Onsite
About The Position
The Senior Regulatory Affairs Specialist is a regulatory subject-matter expert supporting regulatory data integrity, regulatory process excellence, standards assessments, and the implementation of regulatory systems and digital solutions across Medtronic Neurovascular. The role works across multiple product portfolios and regulatory functions to improve data quality, support regulatory initiatives, coordinate cross-functional assessments, and maintain accurate regulatory information across business systems. The Neurovascular business develops technologies for treating stroke and other neurovascular conditions. Regulatory Affairs partners with product development, quality, labeling, clinical, and commercial functions to support global regulatory compliance and product availability. This role is based in Irvine, California, follows an onsite work model, and requires no travel.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
