Quality and Regulatory Affairs Manager

IDx LLC

Coralville, IA Technology / Business & Supply Chain
What We Are Looking For:
IDx is looking for a highly driven, detail-oriented individual to help manage our quality assurance and regulatory compliance efforts. Working in a team setting, the candidate will lead development, implementation, and maintenance of the company’s quality systems and policies. They will also have an opportunity to understand – and, in some cases, help to inform the development of – the regulatory and legal process for clearing start-of-the art software devices through FDA and other government bodies. By understanding, communicating, training, and enforcing compliance standards, our Quality and Regulatory Affairs Manager will help accomplish IDx’s core quality assurance and business objectives.

This particular role requires affinity with quality assurance and ISO-standard/FDA compliance, or work in a similarly detail-oriented field. IDx operates within the regulated medical device industry and is following a highly structured development process that requires extensive documentation and record keeping.

Requirements:
  • Bachelor’s degree or higher 
  • Experience working with complicated regulatory standards or direct work experience in a strictly regulated industry such as medicine, aerospace, automotive, or legal
  • Exceptional analytical and organization abilities
  • Ability to derive joy from navigating complicated regulatory frameworks
  • Obsessive attention to detail
  • Genuine commitment to team work in a fast-paced, entrepreneurial environment
  • Desire to own decisions and take responsibility for outcomes
  • Strong verbal and written communication skills

What will help you in this role:
  • Experience with CE certification and FDA clearance, US and international medical device and data privacy regulations, and Quality Management System maintenance, including complaint handling, CAPA investigations, and internal audits. 

The rigors and challenges of work at IDx are not for everyone, but the team here has some amazing opportunities to:
  • Work with world-renowned doctors who are pushing the limits of machine learning in medicine.
  • Build upon regulatory precedent to revolutionize health tech.
  • Tackle complex problems/projects with the highest levels of quality and execution for audiences that include top technologists, the FDA, and world-leading healthcare providers.
  • Push the accessibility and quality of healthcare to new heights to improve the lives of millions of people.

Additional Considerations:
  • IDx is located in Coralville, IA.  Our office has free parking and our average commute is less than 10 minutes.

How to apply:
If you’re interested in learning more about working at IDx, check out eyediagnosis.net/careers
And if you’re ready to help our team build the future of healthcare, send us your resume by clicking apply now today!

About IDx:
At IDx, we believe that automation has the potential to transform the quality, accessibility, and affordability of medical diagnosis. IDx is expanding its team to launch the first autonomous AI diagnostic system cleared by the FDA for use in the front-lines of healthcare.

IDx employees share in the returns of the commercial success they drive. IDx offers a fair salary and benefits package, augmented with an equity stake in the company. We are a private company with substantial funding and a deep product pipeline. Your work will be instrumental in driving IDx’s long-term value.
Applying for:

Quality and Regulatory Affairs Manager

IDx LLC

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Job ID: 66184

Posted 20 days ago

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