Regulatory Strategy Lead for Life Sciences AI Tools

Inquisito Labs; Concord (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A software development company in Concord, California is seeking an experienced Regulatory Affairs expert to shape product strategy and support regulatory workflows. The ideal candidate will have over 8 years of experience in FDA regulatory pathways and global submissions, focusing on innovative tool development for compliance processes. Responsibilities include defining product direction and contributing to go-to-market strategy. This role offers a unique opportunity to make a significant impact in the life sciences industry.

Qualifications

• 8+ years experience in Regulatory Affairs.
• Hands-on experience with FDA or global regulatory submissions.
• Experience with pathways such as 510(k), De Novo, PMA, IDE, IND/NDA, or similar.

Responsibilities

• Help define product direction for tools supporting regulatory submission workflows.
• Provide domain expertise on FDA regulatory pathways.
• Identify key pain points in current regulatory processes.

Skills

FDA regulatory pathways

Global regulatory submissions

Regulatory documentation

Medical device industry experience

Job description

A software development company in Concord, California is seeking an experienced Regulatory Affairs expert to shape product strategy and support regulatory workflows. The ideal candidate will have over 8 years of experience in FDA regulatory pathways and global submissions, focusing on innovative tool development for compliance processes. Responsibilities include defining product direction and contributing to go-to-market strategy. This role offers a unique opportunity to make a significant impact in the life sciences industry.