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Senior Regulatory Intelligence Specialist - Alpharetta, GAAlpharetta, Georgia, United States
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Senior Regulatory Intelligence Specialist - Alpharetta, GA

  • US
    Alpharetta, Georgia, United States
  • US
    Alpharetta, Georgia, United States
Jetzt Bewerben

Über

Requisition ID: 7161
Job Title: Senior Regulatory Intelligence Specialist - Alpharetta, GA
Job Country: United States (US)
Here at Avanos Medical, we passionately believe in three things:
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. For more information, visit .
Essential Duties and Responsibilities:
Avanos is seeking a Senior Regulatory Intelligence Specialist to lead and coordinate the company's Regulatory Intelligence (RI) program through the External Requirements governance process.
This role is responsible for monitoring global regulatory developments, standards updates, and relevant enforcement trends to support proactive compliance and informed business decision-making. The position partners across Regulatory Affairs, Quality, R&D, PMO, Clinical, and Commercial teams to ensure regulatory changes are identified, evaluated, communicated, and appropriately routed for assessment and implementation.
The ideal candidate is a strategic and collaborative regulatory professional who can synthesize complex information, operate across functions, and help build scalable Regulatory Intelligence processes within a growing organization.
Key Responsibilities:
Regulatory Intelligence & Monitoring
Monitor global medical device regulations, standards, guidance documents, and health authority communications. Identify and communicate regulatory developments that may impact Avanos products, processes, labeling, submissions, or market access. Monitor relevant enforcement and compliance trends, including warning letters, safety communications, recalls, and postmarket signals. Escalate significant or emerging regulatory risks to appropriate stakeholders for evaluation. External Requirements Governance
Own and facilitate the External Requirements Review Board (ERRB) process. Coordinate regulatory and standards impact assessments across cross-functional teams. Track implementation visibility and support alignment of regulatory actions and priorities. Support ongoing regulatory readiness activities and governance processes. Cross-Functional Collaboration
Partner with Regulatory Affairs, Quality, R&D, PMO, Clinical, Commercial, and International teams to support coordinated evaluation of regulatory changes. Translate complex regulatory developments into clear and actionable business impact summaries. Support enterprise awareness and communication of significant regulatory developments. Program Development & Continuous Improvement
Support ongoing development and maturation of the Regulatory Intelligence framework and operating processes. Maintain reporting, tracking, and communication tools supporting regulatory visibility. Contribute to process improvements that strengthen proactive regulatory planning and organizational readiness.
Qualifications:
Required:
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 officeand be available for onsite workshops when required Preferred:
Experience with Regulatory Intelligence, standards management, or External Requirements governance Familiarity with regulatory monitoring or surveillance tools/databases Experience supporting implementation of new or revised regulations or standards Experience working in a global medical device environment The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.
IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here .
Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.
Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.
Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.
Avanos also offers the following:
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions
  • Alpharetta, Georgia, United States

Sprachkenntnisse

  • English
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