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Sr Regulatory Affairs Spec

Job in Lafayette, Boulder County, Colorado, 80026, USA
Listing for: Medtronic plc
Full Time position
Listed on 2026-02-06
Job specializations:
  • Engineering
    Regulatory Compliance Specialist
Job Description & How to Apply Below
The
** Senior Radio Regulatory Affairs Specialist
** is dedicated to the Acute Care and Monitoring (ACM) Operating Unit. In this role, the specialist supports New Product Development (NPD) programs and product 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 device lifecycle. The specialist additionally works with cross‑functional teams to develop and deploy 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.
** Identify and interpret
** worldwide RF, wireless, and telecommunication regulations and communicate input design requirements to New Product Development teams
** 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
* Expertise in global Telecommunication regulatory frameworks (e.g., FCC, RED, ISED, Japan Radio Law, ACMA) and their application to RF‑enabled devices
* 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.
* Bachelor’s degree required
* Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
* 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.
** Medtronic offers a competitive Salary and flexible Benefits Package
** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:
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, and Simple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees:
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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock…
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