Sr Regulatory Affairs Spec - Radio Frequency

Medtronic•Lafayette, CO

3d•Onsite

About The Position

The Senior Regulatory Affairs Specialist, Radio Frequency, ensures Surgical devices are compliant with global radio, wireless, and telecommunications requirements by overseeing RF regulatory submissions, performing change-management assessments, and maintaining compliance throughout the product lifecycle. The position collaborates closely with Regulatory Affairs teams, cross-functional partners, external test laboratories, certification bodies, and international regulatory representatives to align on requirements and execution. In addition, the role drives the integration of RF compliance into broader quality and regulatory systems, ensuring consistent, scalable, and proactive compliance across all programs. The Senior Regulatory Affairs Specialist, RF, provides technical and regulatory leadership for wireless-enabled medical and non-medical devices, supporting global market access and lifecycle compliance. The role develops and executes RF regulatory strategies for new product development and sustaining programs involving technologies such as Bluetooth®, Wi-Fi, RFID, NFC, UWB, and wireless modules, while ensuring compliance with global telecommunications, wireless, and radio regulations. The specialist collaborates with R&D, Quality, Regulatory Affairs, international teams, test laboratories, and certification bodies to support product certification, regulatory submissions, change assessments, and certification maintenance activities. Responsibilities include interpreting and applying global RF requirements and standards, reviewing RF test documentation, assessing the regulatory impact of product changes, and providing guidance on wireless integration, labeling, and compliance strategies. The role also drives continuous improvement initiatives and integration of RF compliance requirements into product development, quality, and regulatory processes to ensure scalable and proactive compliance across the device lifecycle.

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 RF, wireless, and telecommunications regulations
Demonstrated experience supporting medical, non-medical devices or other highly regulated electronic products
Hands-on experience with wireless technologies including Bluetooth/BLE, Wi-Fi, RFID, NFC, UWB, WLAN, wireless module integration, RF exposure evaluation, EMC testing, and spectrum compliance requirements
Strong understanding of global certification pathways and telecommunications approval processes
Skilled at interpreting complex technical standards
Assessing regulatory impacts of product changes
Collaborating with engineering teams on wireless system architecture
Translating technical requirements into practical compliance strategies that enable efficient global market access

Nice To Haves

Experience supporting medical devices, digital health, or other highly regulated electronic products in global markets.
Demonstrated knowledge of global telecommunications approval frameworks, including FDA-adjacent quality systems and product lifecycle compliance.
Familiarity with international regulatory authorities, certification bodies, and external test laboratory management
Experience serving as a technical mentor or subject matter expert in wireless technologies, regulatory strategy, or compliance program development.

Responsibilities

Develop and execute global RF, wireless, and telecommunications regulatory strategies to support worldwide market access and continued compliance for wireless-enabled devices.
Lead global radio certification activities, including regulatory submissions, technical documentation, certification maintenance, and interactions with telecommunications authorities, test laboratories, and certification bodies.
Provide regulatory support for new product development and lifecycle management activities involving technologies such as Bluetooth®, Wi‑Fi, RFID, NFC, UWB, and wireless modules.
Assess the regulatory impact of product, software, firmware, supplier, manufacturing, and labeling changes on global RF certifications and market access.
Interpret and apply global RF, wireless, and telecommunications regulations, standards, and certification requirements, including ANATEL, NCC, MIC, FCC, ISED, EU RED, UK Radio Equipment Regulations, and related standards.
Review RF test plans, test reports, and technical documentation to ensure compliance with applicable regulatory requirements and standards.
Provide subject matter expertise on wireless technologies, module integration strategies, RF labeling requirements, and certification pathways.
Collaborate with cross-functional teams, international regulatory partners, and external stakeholders to resolve compliance issues and support product launches.
Drive process improvements and integrate RF compliance requirements into product development, quality, and regulatory systems to support scalable and proactive compliance programs.