Medtronic · 13 hours ago
Sr. Regulatory Affairs Specialist - ACM
Lafayette, CO
Full-time
Hybrid
Mid, Senior Level
$92K/yr - $138K/yr
4+ years expMedtronic is a global leader in healthcare technology, dedicated to alleviating pain and restoring health. The Senior Regulatory Affairs Specialist will be responsible for managing regulatory activities related to the Nellcor™ Blood Oxygenation Management Franchise, ensuring compliance and collaboration across various teams.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
Prepare 510(k) submissions and technical documents to support CE mark and other international submissions
Prepare rationales to file documentation for modifications to devices when appropriate
Participate in negotiations and interactions with regulatory authorities during the development and review process
Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team
Support international product registrations as needed
Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
Review promotional and advertising material
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits as needed
Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
Leads or compiles all materials required in submissions, license renewal and annual registrations
Keeps abreast of regulatory procedures and changes
May direct interaction with regulatory agencies on defined matters
Perform other duties as assigned or required
Qualification
Required
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
Practical knowledge of project management
Strong working knowledge and experience with reviewing advertising and promotional materials for medical devices
Ability to manage multiple projects and prioritize tasks on a day by day basis to meet project schedules
Ability to interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
Ability to maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Ability to create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Ability to participate in internal and external audits as needed
Ability to maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
Ability to direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits and inspections
Ability to lead or compile all materials required in submissions, license renewal and annual registrations
Ability to keep abreast of regulatory procedures and changes
Ability to perform other duties as assigned or required
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