FCA Program Manager

December 11

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Medtronic

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10,000+ employees

Founded 1949

⚕️ Healthcare Insurance

Description

• Strategize, coordinate and execute FCAs through strong collaboration with operating unit and regions • Responsible for initiating new FCAs and revisions • Support internal and external audits • Prioritizes patient safety and regulatory compliance by acting swiftly in collaboration with cross functional partners to ensure timely FCA planning and approval • Partner with Operating Unit (OU) and region to drive alignment on FCA strategy and execute per plan by following released procedure steps • Follow the process per procedures, align with OUs as needed to ensure the standard process is followed and executed • Supports continuous improvement projects to increase effectiveness, efficiency, and compliance • Ensures alignment with legal and ethical standards of the organization

Requirements

• Bachelor's degree and minimum of 2 years of relevant experience or advanced degree with minimum of 0 years of relevant experience • Capable of effectively managing multiple demands from a variety of sources • Strong expertise with managing complex situations, comfortable escalating issues and operate in grey area • Excellent written and verbal communication abilities • Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive • Experience supporting internal and external audits • Experience supporting continuous improvement projects

Benefits

• 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 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) • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)