COMPLETE Technical Industry Specialist, Clinical and Regulatory, Amazon Special Project - Seattle

Job Description

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 responsibilities

• Develops and maintains regulatory filings to support Head of Regulatory Affairs such as technical files, adverse event reporting or other health authority applications.
• Creates SOPs to support Clinical and Regulatory Affairs activities
• Conducts regulatory due diligence for select areas of product compliance such as labeling, bench testing, 3rd party certification testing.
• Prepares clinical research documentation subject to regulatory requirements.
• Proposes and negotiates budgets for studies.
• Monitors studies, ensuring site compliance with the protocol and regulatory guidelines.
• Conducts pre-study, initiation, interim, and close-out monitoring and completes reports.
• 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 team
Innovators 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:

Seattle, WA, USA

Basic Qualifications:

Basic Qualifications
• Bachelor’s Degree in Healthcare, Life Sciences or relevant work experience
• 5+ years experience in clinical and/or regulatory related fields
• Experience with GCP and medical device regulations
• Experience with clinical research monitoring and site management, and regulatory filings

Preferred Qualifications:

Preferred Qualifications
• Hands on experience preparing regulatory submissions for marketing authorizations
• Experience preparing metrics to keep management and team informed
• Initiates studies and provides for investigator and staff training
• Comfortable working with high degree of ambiguity, establishing criteria for roles internally vs. externally
• Experience working in a regulated environment with design controls
• Functions independently in the field and interacts with all levels of medical and scientific/engineering professionals
• Knowledge of relevant US and international law, regulations and guidance
• Strong familiarity with ICH, QSR, FDA guidance documents
• CRA Certification (CCRA) and/or Regulatory Affairs Certification (RAC), strongly preferred
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Demonstrated ability to contribute to a continuous learning and process improvement environment


Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.

Pursuant to the Los Angeles Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Our 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 geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. Applicants should apply via our internal or external career site.