Sr Regulatory Operations Spec

Medtronic•Lafayette, CO

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 SENIOR REGULATORY OPERATIONS SPECIALIST – (Lafayette, CO, or Mounds View, MN) Join a diverse team of innovators who bring their world view, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. The Senior Regulatory Operations Specialist position is part of the Acute Care & Monitoring (ACM) Regulatory Affairs Team supporting regulatory compliance processes. Primary responsibilities include leading process improvement and harmonization efforts by developing, implementing, and maintaining systems to capture key regulatory data and performance metrics, as well as streamlining product release. The successful candidate will be instrumental in executing new and improved regulatory operations strategies and regulatory data management of ACM products. The individual will work across our entire portfolio of product data to include Global Item Change (GIC), EU Database on Medical Devices (Eudamed), and rest of world device data requirements. Additional duties include developing internal tools for data analysis.

Requirements

Bachelor’s degree with 4+ years’ of relevant experience, or advanced degree with 2+ years’ of relevant experience.

Nice To Haves

Advanced knowledge of word processing, spreadsheet, database, and graphics presentation applications (Microsoft Office, Smartsheet, Power BI, Documentum, SharePoint, Sitebuilder)
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 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
Motivated self-starter with the ability to perform independently or in teams in a fast-paced environment in response to business-critical assignments.

Responsibilities

Support Clearing Product Blocks and Product Release Activities
Support processes and systems used to meet the data submittal requirements of FDA’s GUDID and other global UDI systems, as necessary.
Solve and prevent issues with systems and processes within tight timelines.
Drive functional collaboration to identify topics or trends that require escalation to functional senior leadership.
Provide technical support to regulatory operations and regulatory affairs personnel that may include data coordination, project status, data review, tracking, regulatory metrics reporting, and providing summaries of regulatory intelligence reports to the regulatory team.
Support enterprise-wide regulatory management systems, including system coordination, training others, developing implementation plans and providing input into system designs.
Perform regulatory operations responsibilities independently with a minimal level of guidance and supervision.
Assist in the monitoring and analysis of the impact of new or changing standards and regulations, and other changes that impact product regulation around the world.
Lead and initiate special projects with minimal direction from manager including collecting/analyzing data and presenting results.

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)