The Opportunity

As the company's Regulatory Affairs leader, you will have overall responsibility for ensuring our strategy translates to action. The role spans product and regulatory strategy, ownership of the relationship and engagements with FDA, CE/IVDR notified bodies and other regulatory bodies, and mission critical guidance and collaboration with our scientific, clinical operations, and quality teams to build, submit and see through PMAs and other applicable market authorizations. The VP of Regulatory Affairs and Compliance will be a seasoned leader who is able to build, scale, and motivate cross-functional teams. This strategic leadership role will lead Universal Dx towards the aggressive growth of business with a focus on intelligent regulatory strategy.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

• Collaboration with Product Development, R&D, Clinical Operations, Manufacturing and Quality to develop, coordinate and execute the regulatory strategies for new product development registrations.
• Develop and implement strategies to ensure compliance with all applicable regulations and standards, including FDA, ISO, and other regulatory bodies.
• Design and execute regulatory strategies to create additional value from screening and diagnostic tests for patients, physicians, and payors.
• Stay abreast of industry trends, regulatory changes, and best practices to proactively address emerging challenges and leverage opportunities.
• Serve as the primary interface for FDA, EMA and other regulatory agencies and have well established relationships with key leaders at these agencies.
• Prepare and review regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
• Liaise with regulatory authorities and participate in meetings and discussions to address regulatory matters.

What you'll bring

• A positive self-driven attitude, capable of figuring out what needs to be done and making it so.
• A demonstrated track record of taking single-site diagnostic products through FDA approval.
• Direct knowledge and experience with developing of a product regulated as a single site PMA (ssPMA).
• Demonstrated ability to lead people (even across departmental lines) and achieve results through others as demonstrated by a clear record of accomplishments.
• Experience working in a matrix environment
• Demonstrated ability to deliver on time, on budget in a fast-paced lean environment
• Excellent interpersonal and communication skills to interface, negotiate and influence multi-disciplinary teams and with different levels of personnel
• Ability and willingness to travel 10% of the time, internationally.

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