Sr Regulatory Affairs Spec
About The Position
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Senior Radio Regulatory Affairs Specialist is responsible for leading global RF/Wireless regulatory compliance activities for RF‑enabled devices within the Acute Care and Monitoring (ACM) Operating Unit throughout the product lifecycle. 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. The ideal candidate has 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.
Requirements
- Minimum Requirements Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
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
- 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.
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.
Benefits
- Medtronic offers a competitive Salary and flexible Benefits Package
- We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
