Medtronic

Senior Regulatory Operations Specialist

Medtronic

full-time

Posted on:

Location Type: Office

Location: Lafayette • Colorado • Minnesota • United States

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Salary

💰 $94,400 - $141,600 per year

Job Level

Senior

About the role

  • Leading process improvement and harmonization efforts by developing, implementing, and maintaining systems to capture key regulatory data and performance metrics
  • Streamlining product release
  • Supporting Clearing Product Blocks and Product Release Activities
  • Supporting processes and systems used to meet FDA’s GUDID and other global UDI systems
  • Solving and preventing issues with systems and processes within tight timelines
  • Driving functional collaboration to identify topics or trends that require escalation to functional senior leadership
  • Providing technical support to regulatory operations and regulatory affairs personnel
  • Assisting in the monitoring and analysis of the impact of new or changing standards and regulations
  • Leading and initiating special projects with minimal direction from manager

Requirements

  • Bachelor’s degree with 4+ years of relevant experience, or advanced degree with 2+ years of relevant experience
  • 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
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
  • 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)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
process improvementregulatory data analysisperformance metricsproject managementdata analysistechnical supportsystem implementationproduct release managementGUDID complianceUDI systems knowledge
Soft Skills
self-motivatedexcellent communicationability to multitaskinfluence without authorityindependententrepreneurial mindsetcollaborationproblem-solvingadaptabilitytime management