People Tech Group Inc Hiring for Healthcare Consultant at United States Full Time

Hi All

Healthcare Consultant

Client: Ivory AI

Location: (Remote)

Position Overview:

We are seeking a Healthcare Consultant to join our team and provide expert guidance in navigating HIPAA compliance and securing FDA clearance or approval for our dental AI products. The ideal candidate will have extensive experience in healthcare regulations, particularly in the dental sector, and a deep understanding of HIPAA requirements and FDA regulatory processes.

Qualifications:

• Bachelor’s degree in healthcare administration, regulatory affairs, or a related field (advanced degree preferred).

• Minimum of 5 years of experience in healthcare consulting, regulatory affairs, or compliance, with a focus on the dental industry.

• In-depth knowledge of HIPAA regulations and requirements, with experience implementing HIPAA compliance programs.

• Proven track record of successful FDA submissions and obtaining regulatory clearances or approvals for medical devices or software products (experience with AI technologies preferred).

• Familiarity with quality management systems (QMS) and regulatory standards (ISO 13485, 21 CFR Part 820).

• Strong analytical skills and attention to detail, with the ability to interpret and apply complex regulations and guidelines.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and influence decision-making.

• Self-motivated and proactive, with the ability to work independently and manage multiple projects simultaneously.