AI-powered platform to automate FDA regulatory workflows for life sciences companies and accelerate compliance and development.

Industry: IT Services and IT Consulting
Company Size: 2-10 employees

Inquisito Labs

Savvy Admin PROD

**Inquisito Labs ** is building software for regulatory teams in the life sciences industry. We are an early-stage team of engineers and AI researchers developing advanced tools designed to support regulatory teams.

We are looking for an experienced **Regulatory Affairs expert ** to join us in shaping both the **product and go-to-market strategy **.

This role is ideal for someone with deep experience in **FDA regulatory pathways and global regulatory submissions ** who is interested in helping build innovative tools that support regulatory workflows and compliance processes.

Responsibilities

• Help define product direction for tools supporting regulatory submission workflows

• Provide domain expertise on FDA regulatory pathways (**510(k), De Novo, PMA, IDE, IND, NDA, BLA **) and international regulatory frameworks

• Identify key pain points in current regulatory processes

• Guide development of features that support regulatory documentation, compliance, and submission preparation

• Help identify potential customers and early industry partnerships

• Contribute to go-to-market strategy and industry positioning

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 regulatory processes

• Strong understanding of regulatory documentation and approval processes

• Experience working with **medical device, biotech, pharma, CROs, or regulatory consulting firms **

• Interest in working with a technical team building new solutions for the industry

To Apply

If interested, please send a **short note and your LinkedIn profile via direct message. **

Co-Founder / Head of Regulatory Strategy (MedTech / Life Sciences)

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