Sr Regulatory Affairs Spec jobs in United States
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Medtronic · 16 hours ago

Sr Regulatory Affairs Spec

Medtronic is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life. The Senior Radio Regulatory Affairs Specialist is responsible for leading global RF/Wireless regulatory compliance activities for RF-enabled devices, collaborating with cross-functional teams to ensure compliance throughout the product lifecycle.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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H1B Sponsor Likelynote

Responsibilities

Develop and execute global RF regulatory strategies for new and sustaining products
Identify and interpret worldwide RF, wireless, and telecommunication regulations and communicate input design requirements to New Product Development teams
Prepare and manage global RF technical documentation and certification submissions (e.g., FCC, ISED, RED, MIC)
Act as an RA Extended Core Team Member within NPD projects to ensure RF design input requirements are identified, including RF technical parameters, RF labeling, and country-specific Regulatory requirements
Proactively identify and raise potential risks, provide informed recommendations, and effectively guide cross-functional teams toward compliant and efficient solutions
Communicate with external labs, compliance and certification bodies, and in-country regulatory representatives
Maintain RF compliance databases, regulatory documentation, and OU RF procedures
Collaborate with cross-functional teams to influence development of new or improved of RF-related processes, procedures, and best-practice frameworks

Qualification

Global RF certificationWireless technology integrationRF compliance managementTelecommunication regulationsTechnical documentationSystems engineeringRadio Frequency designCommunicationProject managementTechnical writing

Required

Bachelor's degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
Expertise in global RF certification pathways, integration of wireless technologies such as Wi‑Fi, Bluetooth, RFID, NFC, UWB, and experience in development of new processes or procedures within an organization
Develop and execute global RF regulatory strategies for new and sustaining products
Identify and interpret worldwide RF, wireless, and telecommunication regulations and communicate input design requirements to New Product Development teams
Prepare and manage global RF technical documentation and certification submissions (e.g., FCC, ISED, RED, MIC)
Act as an RA Extended Core Team Member within NPD projects to ensure RF design input requirements are identified, including RF technical parameters, RF labeling, and country‑specific Regulatory requirements
Proactively identify and raise potential risks, provide informed recommendations, and effectively guide cross-functional teams toward compliant and efficient solutions
Communicate with external labs, compliance and certification bodies, and in‑country regulatory representatives
Maintain RF compliance databases, regulatory documentation, and OU RF procedures
Collaborate with cross-functional teams to influence development of new or improved of RF‑related processes, procedures, and best‑practice frameworks
Ability to interpret RF requirements, such as output power, bandwidth, spurious emissions, and RF exposure, and turn them into clear design and testing requirements
Experience navigating RF certification pathways and determining efficient test strategies
Strong understanding of RF module integration requirements (labeling, exposure, host-device compliance)
Demonstrated success developing global RF regulatory strategies across the product lifecycle
Excellent communication skills, with the ability to collaborate and influence effectively across a matrixed organization
Background in engineering or regulatory affairs, or other technical roles supporting RF‑enabled products
Familiarity with RF technologies such as RFID, Wi‑Fi, Bluetooth, and NFC, including typical compliance requirements

Preferred

Medical device experience
Design Dossier and/or Technical Documentation experience
Technical Writing
May have practical knowledge of project management
Experience with standards analyses and interpretation
Experience in systems engineering
Radio Frequency design engineering

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

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Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.

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 Company
Total Funding
$18.16B
Key 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

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Geoffrey Martha
CEO and Chairman Of The Board Of Directors
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Linnea Burman
SVP & President, Neurovascular
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Company data provided by crunchbase