Regulatory Operations Specialist

Medtronic•Northridge, CA

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 Sitting in the Diabetes Regulatory Operations Team, the Regulatory Operations Specialist will be a key member managing regulatory data attributes, distribution control mechanisms, and preparation and publishing of submissions. This position is an exciting opportunity to work with Medtronic's Diabetes business. 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. The successful candidate will: Have a background working within a Quality System Work cross-functionally and in a matrixed environment Manage multiple projects, prioritizing work based on criticality Have experience with FURLs and UDI data Have experience with and participate in continuous improvement activities Have experience with Regulatory Information Management (RIM) System A Day in the Life Develop key partnerships with stakeholders across functional groups, and regions to align on harmonized processes Manage publishing activities for multiple projects Manage UDI Database including uploading of data to relevant regulatory bodies Manage FURLs Database including uploading of data Support Product Blocks and Product Release Activities

Requirements

Minimum 2 years of experience with a Bachelor’s Degree
Have a background working within a Quality System
Work cross-functionally and in a matrixed environment
Manage multiple projects, prioritizing work based on criticality
Have experience with FURLs and UDI data
Have experience with and participate in continuous improvement activities
Have experience with Regulatory Information Management (RIM) System

Nice To Haves

Strong project management skills.
Proven ability to work globally.
Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
Excellent written and oral communication skills.
Ability to think strategically and execute methodically.
Ability to quickly learn new computer technology software packages with minimal training
Ability to work effectively within a matrix environment
Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
Ability to influence cross-functional teams without formal authority.
Strong attention to detail and an ability to deal with ambiguity

Responsibilities

Develop key partnerships with stakeholders across functional groups, and regions to align on harmonized processes
Manage publishing activities for multiple projects
Manage UDI Database including uploading of data to relevant regulatory bodies
Manage FURLs Database including uploading of data
Support Product Blocks and Product Release Activities

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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
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)