Audit Compliance Manager - Diabetes

Medtronic • Los Angeles, CA

2d • Hybrid

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life In this exciting role as an Audit Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Audit Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. The individual in this role must be comfortable coaching all employees on audit readiness and working professionally with others to reach understanding and agreement, as necessary. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. This is a hybrid capacity position which requires 3 days in the office and 2 days working in a remote capacity. Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines Develops, implements, administers and certifies compliance policies, procedures, and practices Provides compliance advice, investigates complaints and verifies deficiencies are corrected Develops employee communication and training programs that focus on the elements of a companywide compliance program Ensure alignment with legal and ethical standards of the organization Manage internal team responsibilities as assigned Analyzes metrics and audits functional compliance program Maintains current knowledge of laws, regulations, and industry guidance that impact the company's compliance program

Requirements

• Bachelor’s degree in engineering, Science or technical field
• 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry
• OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience

Nice To Haves

• Capable of effectively managing multiple demands from a variety of sources
• Strong expertise with managing complex situations, comfortable escalating issues and operating in grey area
• Excellent written and verbal communication abilities
• Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc
• Experience supporting continuous improvement projects
• Strong critical thinking and analytical skills

Responsibilities

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
• Develops, implements, administers and certifies compliance policies, procedures, and practices
• Provides compliance advice, investigates complaints and verifies deficiencies are corrected
• Develops employee communication and training programs that focus on the elements of a companywide compliance program
• Ensure alignment with legal and ethical standards of the organization
• Manage internal team responsibilities as assigned
• Analyzes metrics and audits functional compliance program
• Maintains current knowledge of laws, regulations, and industry guidance that impact the company's compliance program

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
• Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees