Kaleido

Product Specialist

• You act as the primary contact and trainer for medical professionals
• You support patients and clinic teams during the product onboarding phase
• You provide clinical expertise to support the account management team during the sales process
• You professionally present Kaleido at trade shows and training events
• You systematically collect market feedback and contribute improvement suggestions to our product development
• You work closely with Sales, Support and Marketing

Clinical Product Specialist

Compliance

• Develop and execute U.S. regulatory strategies to support product clearance and lifecycle management.
• Prepare, submit, and maintain FDA filings (e.g., 510(k), device listings, establishment registration).
• Act as primary liaison with the FDA, including participation in meetings and responding to questions post-submission.
• Set up and manage U.S. post-market systems: complaints, vigilance, MDR, recalls, and surveillance.
• Integrate regulatory requirements into our Quality Management System (Egnyte/ETQ).
• Monitor evolving FDA regulations and translate them into actionable guidance.
• Collaborate with cross-functional teams (Quality, Engineering, Clinical) to ensure compliance and readiness for scale.

Clinical Product Specialist

Regulatory Affairs Manager