Senior Regulatory Intelligence Specialist - Alpharetta, GA
On-site · Alpharetta, Georgia, United States
Job Summary
Lead and coordinate Avanos' Regulatory Intelligence program through External Requirements governance, monitoring global medical device regulations, standards updates, and enforcement trends to support proactive compliance and informed business decision-making. Collaborate across Regulatory Affairs, Quality, R&D, PMO, Clinical, and Commercial to identify, evaluate, communicate, and route regulatory changes for assessment and implementation. Own and facilitate the External Requirements Review Board (ERRB) process, track implementation visibility, and support regulatory readiness activities. Translate complex regulatory developments into clear, actionable business impact summaries and contribute to evolving Regulatory Intelligence frameworks and governance processes. This role requires cross-functional collaboration to ensure regulatory actions and priorities are communicated and appropriately acted upon.
Required Qualifications
- Bachelor’s degree in science, engineering, regulatory affairs, or related discipline
- 5+ years of experience in Regulatory Affairs, Quality, Engineering, or another regulated environment
- Working knowledge of global medical device regulations and international standards
- Strong analytical, organizational, and communication skills
- Ability to manage multiple priorities and work effectively across functions
- Demonstrated ability to operate independently in a matrixed environment
- Position is based in Alpharetta, GA with the ability to work at least three days a week (ideally Tuesday-Thursday) in office and be available for onsite workshops when required
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