Regulatory Lead

Summary

The Regulatory Leader will play a crucial role in ensuring compliance with regulatory requirements and standards in the industry globally. The Regulatory Leader’s responsibilities will include developing and implementing regulatory strategies, interacting with the FDA and other regulatory agencies, collaborating with cross-functional teams, and ensuring that products and processes achieve and continue to meet all relevant regulatory guidelines. This role requires strong attention to detail, exceptional communication skills, and a deep understanding of regulatory processes and requirements.

Medi Beacon is a medical technology company focused on advancing fluorescent tracer agents and transdermal detection technology to provide vital and actionable measurement of organ function.

Summary of Position The Regulatory Leader will play a crucial role in ensuring compliance with regulatory requirements and standards in the industry globally. The Regulatory Leader’s responsibilities will include developing and implementing regulatory strategies, interacting with the FDA and other regulatory agencies, collaborating with cross-functional teams, and ensuring that products and processes achieve and continue to meet all relevant regulatory guidelines.

This role requires strong attention to detail, exceptional communication skills, and a deep understanding of regulatory processes and requirements.

Medi Beacon Inc. Overview Medi Beacon is a medical technology company focused on advancing fluorescent tracer agents and transdermal detection technology to provide vital and actionable measurement of organ function.

Measurements of organ function at the point of care and the general application of fluorescent agent technology have the potential to provide information that will help healthcare providers to fundamentally change the standard of care in numerous clinical situations. It is our mission to provide doctors with information that empowers them to make better decisions faster. Use of the technology in a clinical setting offers the possibility for clinicians to provide improved patient care over current practice.

Medi Beacon Inc. performs clinical studies with our recently approved transdermal GFR system designed to measure and monitor kidney function. Completion of the clinical human studies, regulatory approval in key markets including the US, and subsequent commercialization of the Transdermal GFR System is an on-going focus of the Company. Application of our fluorescent agent technology in several clinical and research areas is also on-going.

The Regulatory Leader will have the opportunity to be part of a rapidly growing technical team. Medi Beacon is focused on bringing to market innovative products, which can meet large unmet medical needs while at the same time contributing to the reduction of overall health care system costs.

Essential Duties And Responsibilities

• Hands-on management of medical device and combination product projects to ensure global regulatory compliance.
• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
• Collaborate with cross-functional teams including R&D, Quality Assurance, Clinical, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.
• Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market approval submissions, de novo, IDE, IND, annual reports and post-market surveillance reports.
• Liaise with regulatory authorities and act as a contact during inspections, audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
• Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are…