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

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.

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