Location: Remote within the United States (Periodic travel to Lancaster, California, as needed)
Engagement Type: Independent Contractor (1099)
Compensation: Hourly or project-based compensation, commensurate with experience and scope of work. Equity participation may be considered through the Company’s Equity Incentive Plan, subject to Board approval and applicable law.

About MYDENTALWIG

MYDENTALWIG is developing a new category of healthcare technology called Ingestion Intelligence™.

Our mission is to create the world’s first platform capable of detecting human ingestion behavior in real time and translating it into predictive metabolic intelligence through advanced sensing technologies, artificial intelligence, and cloud computing.

As our technology platform evolves, we anticipate ongoing interaction with the U.S. Food and Drug Administration (FDA) to support multiple product generations and future regulated healthcare applications.

We believe regulatory strategy should be integrated into innovation from the earliest stages of product development.

About the Opportunity

MYDENTALWIG is seeking an experienced Regulatory Affairs Consultant to serve as the Company’s principal FDA advisor during Phase I development.

This role is ideal for an accomplished regulatory professional who enjoys working with innovative technologies and helping early-stage companies establish a sound regulatory foundation.

Rather than functioning as an external reviewer, you will become an integral member of our multidisciplinary team, providing strategic regulatory guidance as our products evolve from concept through prototype development and future commercialization.

This engagement is expected to evolve alongside the Company, with the potential for expanded responsibilities as MYDENTALWIG grows.

Key Responsibilities

• Advise executive leadership on FDA regulatory strategy for current and future products.
• Assess product concepts and recommend appropriate regulatory pathways.
• Participate in product development discussions to ensure regulatory considerations are incorporated early in the design process.
• Advise on intended use, indications for use, product claims, and product positioning.
• Provide guidance regarding Software as a Medical Device (SaMD), artificial intelligence, digital health technologies, and medical devices, as applicable.
• Assist in planning FDA Pre-Submission (Q-Submission) meetings and communications.
• Review engineering and technical documentation for regulatory readiness.
• Advise on design controls, risk management, verification, validation, and documentation requirements.
• Support development of the Company’s Quality Management System.
• Coordinate with outside legal counsel, engineering teams, and clinical advisors, as appropriate.
• Monitor evolving FDA guidance relevant to artificial intelligence and digital health technologies.
• Provide strategic input during investor and due diligence activities regarding the Company’s regulatory roadmap.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, Engineering, or a related discipline.
• At least ten years of experience supporting FDA-regulated medical products.
• Demonstrated experience interacting directly with the FDA.
• Experience developing regulatory strategies for innovative medical technologies.
• Strong knowledge of FDA regulations applicable to medical devices and digital health products.
• Excellent written, verbal, and interpersonal communication skills.

Preferred Qualifications

• RAC (Regulatory Affairs Certification).
• Experience with Software as a Medical Device (SaMD).
• Experience supporting artificial intelligence or machine learning-enabled healthcare technologies.
• Familiarity with FDA guidance related to AI-enabled medical products.
• Experience supporting early-stage medical technology companies.
• Experience participating in FDA Q-Submission (Pre-Sub) meetings.
• Knowledge of ISO 13485, risk management principles, and design control requirements.

Compensation

• Competitive hourly or project-based consulting fees based on qualifications and experience.
• Flexible engagement designed around project milestones and regulatory activities.
• Opportunity for equity participation through the Company’s Equity Incentive Plan, subject to Board approval and applicable law.
• Potential to transition into a long-term leadership role as the Company expands.

Why Join MYDENTALWIG?

MYDENTALWIG is building technology at the intersection of biomedical sensing, artificial intelligence, and preventive healthcare.

As our Regulatory Affairs Consultant, you will help establish the regulatory strategy for a platform designed to support multiple future healthcare applications. Your guidance will influence foundational product decisions, regulatory planning, and long-term commercialization strategy.

If you are excited by novel technologies, collaborative problem-solving, and helping innovative companies navigate the regulatory landscape responsibly, we encourage you to apply.

To apply, please submit your résumé, a summary of relevant regulatory experience, and examples of FDA programs or medical technologies you have supported.