We are a startup that just received a new round of funding so now we are hiring! We are developing a new software product that will revolutionize the detection of skin diseases. This is your opportunity to help develop a product that addresses the root cause for over 100 million doctor’s visits a year in the US.
What you will be responsible for
You will be responsible for all polices and activities in the areas of quality, compliance, and FDA submission. This includes ensuring that we all operate according to our quality system to provide products that meet customer requirements, while maintaining compliance with all applicable regulations (state, federal and international):
- Provide leadership in directing companywide quality assurance
- Build and maintain a Quality System and processes to ensure compliance with FDA Quality System Regulations
- Prepare and oversee submissions to FDA
- Represents us before regulatory authorities
What we require
Extensive experience in medical device Quality Assurance and Regulatory Affairs:
- Excellent knowledge of FDA medical device regulations
- Direct experience in implementing Quality Management Systems
- Prior hands-on experience with 510(k) submissions
- Familiarity with Swissmedic medical device regulations is a plus
- Experience managing a small regulatory department is desirable
- CQM and RAC certifications are a plus
- Ability to write clear, concise, and grammatically-correct English
- Superior project management skills with the ability to drive projects; delivering project goals on time, within budget in a fast paced environment
- College degree or equivalent required, preferably in engineering or science
What to expect
- We are a startup, so everyone wears multiple hats! Be ready to roll up your sleeves and tackle novel tasks. If you need a new tool, there is no requisition-form in triplicate. Just buy the tool that makes you productive. Or better yet, find an online SaaS version that scales with us as we grow.
- We have a virtual office, so for now you can do much of your work from home. Face-to-face meetings will be required, so some domestic and possibly international travel is necessary. If you live near Boston or LA then you won’t have to travel nearly as much.
- We are developing Class I and II medical devices, so we will have to abide by lots of FDA regulations (but not nearly as many as for Class III).
We do not discriminate based on citizenship status, but we require authorization to work in the US (we cannot help you acquire such authorization).