Medtronic · 11 hours ago
Sr Regulatory Operations Spec
Lafayette, CO
Full-time
Onsite
Mid, Senior Level
$94K/yr - $142K/yr
4+ years expMedtronic is a global leader in medical technology and solutions, dedicated to improving healthcare access and equity. The Senior Regulatory Operations Specialist will support regulatory compliance processes by leading process improvement efforts, developing systems for regulatory data management, and collaborating across product portfolios to enhance regulatory operations. This role includes responsibilities such as supporting product release activities, providing technical support, and leading special projects with minimal direction.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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
Qualification
Required
Bachelor's degree with 4+ years' of relevant experience, or advanced degree with 2+ years' of relevant experience
Preferred
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
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
BioWorld Financial Watch
2026-01-25
Company data provided by crunchbase