Regulatory Affairs Manager
At IDx, we believe that automation has the potential to transform the quality, accessibility, and affordability of medical diagnosis. IDx is expanding its team supporting the development of autonomous Artificial Intelligence (AI) diagnostic systems cleared by the FDA.
As a growing company, every member of our team plays a fundamental role in our success and IDx employees share in the returns of the success they help 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.
What We Are Looking For:
The Regulatory Affairs Manager:
- Manages 3rd party regulatory consultants
- Manages new jurisdiction regulatory product registrations, licensing requirements, and required documentation
- Write submission documents for FDA, Notified Bodies, and other regulatory agencies; develop responses to questions or deficiency letters from regulatory agencies.
- Manages development of new 510(k)s
- Maintains and updates CE Certificates with new product codes
- Develop and maintain Technical Files for CE marking
- Conducts IDx gap analyses in anticipation of regulatory changes and implements any needed actions
- Assess regulatory impact of post market changes on labeling, design, or manufacturing process changes (e.g., determines if a new 510(k) is needed)
- Performs 21 CFR 803 medical device reporting (MDR) analysis and review
- Manages MDR database maintenance and procedure
- Reviews events in accordance with MEDDEV Guidelines on a Medical Device Vigilance System
- Bachelor’s or master’s degree in life sciences or related discipline.
- 3+ years experience in a regulatory affairs role in the medical device or pharmaceutical industry.
- Proven leadership and initiative.
- Excellent written and verbal communication skills.
- Applicants must not now or in the future need IDx to sponsor an immigration case for employment (for example, H-1B or other employment-based immigration cases).
What will help you in this role:
- Experience with relevant US and international medical device regulations and standards, including 21 CFR 820 and ISO 13485, 21 CFR 803, and MEDDEV Guidelines for medical device reporting.
- Experience drafting and editing regulatory documents, such as FDA pre-submissions and 510k’s.
- Exceptional analytical and organizational skills
- Genuine commitment to team work in a fast-paced, entrepreneurial environment
- Desire to own decisions and take responsibility for outcomes
The rigors and challenges of work at IDx are not for everyone, but the team has some amazing opportunities to:
- Work with world-renowned doctors who are pushing the limits of machine learning in medicine.
- Build upon research and distribution partnerships with IBM’s Watson Health team 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.
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 at [email protected]