Willow Laboratories Visa Sponsorship USA

Job Summary:

Willow Laboratories is a health and wellness innovator harnessing the power of artificial intelligence and clinical evidence to drive meaningful change in healthcare. We are using cutting-edge technology, data, and a highly engaging user experience to revolutionize chronic disease management and prevention. We are seeking a Director of Regulatory Affairs with deep expertise in wearable, minimally invasive electromechanical medical devices and a strong track record of leading successful 510(k) submissions. This individual will define and execute global regulatory strategies for innovative, patient-contact technologies that require high standards of safety, reliability, and biocompatibility. The Director will partner cross-functionally with R&D, Quality, Clinical, and Operations to support product development, ensure regulatory compliance, and enable efficient market access. The ideal candidate brings experience navigating regulatory pathways for complex devices, including systems that integrate hardware, software, and, where applicable, drug delivery components.

Duties & Responsibilities:

- Lead the preparation, submission, and negotiation of 510(k) premarket notifications and support EU MDR compliance.
- Develop and implement global regulatory strategies for wearable and minimally invasive medical devices across the product lifecycle.
- Serve as the primary point of contact with the FDA and other global regulatory authorities.
- Provide regulatory guidance on design controls, risk management, biocompatibility, usability engineering, and system safety.
- Support regulatory aspects of device software, cybersecurity, and connected system considerations.
- Provide regulatory input on post-market product changes and lifecycle management.
- Review and approve labeling, Instructions for Use, and promotional materials to ensure compliance.
- Ensure compliance with applicable standards and regulations, including FDA QSR, ISO 13485, ISO 14971, IEC 60601, ISO 10993, and EU MDR.
- Collaborate with R&D and Clinical teams to support human factors activities and clinical investigations.
- Monitor post-market obligations, including vigilance reporting and surveillance activities.
- Build and maintain strong relationships with regulatory authorities, notified bodies, and industry groups.
- Develop and mentor the Regulatory Affairs team, fostering technical and strategic expertise.
- Prepare the organization for regulatory inspections and audits, ensuring readiness at all times.

Minimum Qualifications and Experience

- Knowledge of global regulatory frameworks including FDA QSR, ISO 13485, ISO 14971, EU MDR, and post-market requirements.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong leadership and team development experience.
- Exceptional communication and stakeholder management skills.
- Ability to travel up to 25% domestically and internationally.

Preferred Qualifications

- Advanced degree or Regulatory Affairs Certification (RAC).
- Strong experience with combination products (device + drug delivery).
- Experience with wearable or continuous monitoring systems.
- Familiarity with connected medical devices and digital health integrations.
- Experience in high-growth, innovation-driven medical device environments.
- Experience working with international regulatory authorities and notified bodies.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore, the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Location:

Position is located on-site in Irvine, CA

This salary range represents the full compensation band for this role. Most new hires are typically placed toward the middle of the range based on experience, skills, education, and job-related qualifications. Compensation at the upper end of the range is reserved for candidates with exceptional experience or those who significantly exceed the role’s core requirements.