Senior Regulatory Affairs Specialist - Onsite

About the role

The Senior Regulatory Affairs Specialist supports regulatory compliance and product lifecycle management activities for a portfolio of neurovascular medical devices. This role is based onsite in Irvine, California, with an expectation to work on-site at least 4 days per week to support cross-functional collaboration. Travel is expected to be minimal.

Responsibilities

• Provide regulatory strategy and guidance for product modifications and lifecycle management activities.
• Prepare and submit Pre-Submission, Investigational Device Exemption (IDE), IDE Supplement, Premarket Approval (PMA), PMA Supplement, and 510(k) regulatory submissions.
• Support technical documentation development and maintenance for European Union Medical Device Regulation (EU MDR) compliance and CE Mark activities.
• Assess product, labeling, manufacturing, and process changes to determine regulatory impact and document regulatory decisions.
• Partner with engineering, quality, clinical, marketing, and other cross-functional teams to ensure regulatory requirements are incorporated throughout the product lifecycle.
• Serve as the primary regulatory representative with regulatory authorities and Notified Bodies, including support for agency interactions and responses.
• Review promotional and advertising materials for compliance with applicable regulatory requirements.
• Maintain regulatory records, procedures, and submissions while supporting internal and external audits as required.

Requirements

• Bachelor's degree in Science or Engineering and 4+ years of medical device regulatory affairs experience; or an advanced degree and 2+ years of medical device regulatory affairs experience.
• Experience supporting U.S. Food and Drug Administration (FDA) medical device submissions and regulatory compliance activities.
• Experience managing multiple regulatory projects in a regulated medical device environment.
• 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.

Preferred Qualifications

• Regulatory Affairs Certification (RAC).
• Experience with 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA), or international medical device submissions.
• Knowledge of European Union Medical Device Regulation (EU MDR), ISO 13485, and ISO 14971 requirements.
• Experience supporting global regulatory compliance and market access activities.

Benefits

• Health, Dental, and Vision insurance.
• Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and Long-term disability leave.
• Dependent daycare spending account and Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans, including the Medtronic Incentive Plan (MIP).
• 401(k) plan plus employer contribution and match.
• Paid time off and Paid holidays.
• Employee Stock Purchase Plan and 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).

Pay

Salary ranges for U.S. locations (excluding Puerto Rico) are $92,000.00 - $138,000.00 USD. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.