Directors of Regulatory Affairs with strong SaMD (IEC 62304) and Class III Medical Device experience interested in working for an early stage start-up creating pioneering life saving technologies are encouraged to apply. A passion for AI / ML's impact on healthcare is a big plus.
A) Here are some of the things you'll be doing:
- Drafting and executing FDA submissions for medical devices (including Class III) and devices incorporating hardware and software.
- 510(k) and PMA applications, post-market surveillance, and regulatory audits.
B) You will be rewarded with:
- A competitive compensation package
- A very competitive equity package
- Generous benefits
Directors and Senior Directors looking for a VP title will also be considered provided salary expectations are in range.