Sr Regulatory Affairs Spec

Medtronic•Lafayette, CO

1d•$92,000 - $138,000•Onsite

About The Position

The Sr. Regulatory Affairs Specialist, RF is responsible for managing global RF/Wireless regulatory compliance activities for RF enabled devices within the Acute Care and Monitoring (ACM) Operating Unit (OU). The Sr. Regulatory Affairs Specialist, RF is dedicated to the ACM OU. In this role, the specialist supports both New Product Development (NPD) programs and lifecycle maintenance activities across the RF enabled device portfolio. The specialist collaborates closely with Regulatory Affairs colleagues, cross functional partners at all levels, external test laboratories and certification bodies, and International Regulatory Affairs teams to ensure ongoing compliance with global RF, wireless, and telecommunication requirements. They have oversight of global RF submissions, perform change management assessments, and are responsible for ensuring RF compliance throughout the device lifecycle. The specialist additionally works with cross functional teams to develop new processes and improve existing procedures to integrate RF compliance requirements into ACM’s broader quality and regulatory systems, ensuring consistent, scalable, and proactive compliance across all programs. The ideal candidate has expertise in global RF certification pathways, integration of wireless technologies such as Wi Fi, Bluetooth, RFID, NFC, UWB, and in applying regulatory procedures and frameworks used across multiple businesses.

Requirements

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 Telecommunication regulatory frameworks (e.g., FCC, RED, ISED, Japan Radio Law, ACMA) and their application to RF‑enabled technologies such as RFID, Wi‑Fi, Bluetooth, and NFC
Ability to interpret RF technical requirements, such as output power, bandwidth, spurious emissions, and RF exposure, and turn them into clear design input and test 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 compliance strategies across the product lifecycle
Background in engineering, regulatory affairs, or other technical roles supporting RF enabled product development
Consistently applies strong communication skills; is proficient in clear, concise writing; is confident speaking up in cross‑functional settings; and leverages influence within teams and stakeholders across a matrixed organization.

Nice To Haves

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.

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.
Oversee the maintenance of RF databases, regulatory documentation, and OU RF procedures
Collaborate with ACM cross-functional teams to influence the development of new or improved of RF‑related processes, procedures, and best‑practice frameworks

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)