We are a passionate team of doers that apply cutting-edge advances in technology to solve real-world problems and transform our customers' experiences. As a Technical Industry Specialist, you will be working with a unique and gifted team developing exciting products for customers and collaborating with cross-functional teams.Amazon is looking for a Technical Industry Specialist to join an exciting project team working to build a best in class product. Our team is fast paced, highly collaborative and is organized like a startup.Here at Amazon, we embrace our differences. We are committed to furthering our culture of inclusion. We have thirteen employee-led affinity groups, reaching 40,000 employees in over 190 chapters globally. We are constantly learning through programs that are local, regional, and global. Amazon's culture of inclusion is reinforced within our 16 Leadership Principles, which remind team members to seek diverse perspectives, learn and be curious, and earn trust.Our team highly values work-life balance, mentorship and career growth. We believe striking the right balance between your personal and professional life is critical to life-long happiness and fulfillment. We care about your career growth and strive to assign projects and offer training that will challenge you to become your best.Key job responsibilitiesDevelops and maintains regulatory filings to support Head of Regulatory Affairs such as technical files, regulatory consultation meetings or other health authority applications.Conducts regulatory due diligence for relevant areas of product compliance such as labeling, bench testing, 3rd party certification testing.Supports regulatory assessments for product changes pre- and post-market subject to regulatory requirements.Assists in the creation and implementation of regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.Encourages and supports knowledge-sharing within team and external groups.About the teamInnovators wanted! Are you an entrepreneur? A builder? A dreamer? This role is part of an Amazon Special Projects team that takes the company's Think Big leadership principle to the extreme. We focus on creating entirely new products and services with a goal of positively impacting the lives of our customers. No industries or subject areas are out of bounds. If you're interested in innovating at scale to address big challenges in the world, this is the team for you.We are open to hiring candidates to work out of one of the following locations:Milpitas, CA, USA | Seattle, WA, USABachelor's Degree in Healthcare, Life Sciences, Engineering or relevant work experience5+ years experience in regulatory affairs fieldExperience with GCP, QMS and medical device regulationsExperience with regulatory filingsHands on experience preparing regulatory submissions for marketing authorizationsExperience preparing metrics to keep management and team informedComfortable working with high degree of ambiguity, establishing criteria for roles internally vs. externallyExperience working in a regulated environment with design controlsFunctions independently in the field and interacts with all levels of medical and scientific/engineering professionalsKnowledge of relevant US and international law, regulations and guidanceStrong familiarity with QSR, FDA guidance documentsRegulatory Affairs Certification (RAC), strongly preferredStrong interpersonal skills with the ability to influence others in a positive and effective mannerDemonstrated ability to contribute to a continuous learning and process improvement environmentOur compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $91,800/year in our lowest geographic market up to $185,000/year in our highest geograp