Global Medical Device & Life Sciences Policy Director

About the role

The role is global in scope, but will involve collaboration with Medical Device and Life Sciences regulatory affairs, legal, and policy teams across the globe. We are seeking a leader who can keep up with the fast-paced environment of software development and an evolving regulatory landscape.

Responsibilities

• Monitor and analyze regulatory developments impacting Oracle’s business from the Food & Drug Administration and similar global regulators.
• Monitor and analyze regulations and guidance impacting use of real-world evidence, data analytics, AI in drug development, and other issues impacting the use of technology in the life sciences industry.
• Develop and maintain relationships with IMDRF, U.S. Food & Drug Administration and other global regulators.
• Participate actively in trade association meetings and committees.
• Participate in conferences and other events and engage in opportunities for thought leadership, such as speaking and writing opportunities.
• Collaborate with medical device regulatory affairs, legal, life sciences regulatory policy, and government affairs teams to develop policy positions and coordinate advocacy efforts.
• Lead strategic policy advocacy efforts with respect to the U.S. Food and Drug Administration and coordinate efforts with IMDRF other similar global regulators.
• Develop executive summaries and briefings.

Qualifications

• Bachelor's degree - advanced degree preferred.
• A regulatory policy expert with 15+ years of experience with med-tech and/or software as a medical device.
• Experience working at the U.S. Food & Drug Administration preferred.
• Experience with regulatory policy at the intersection of technology and the life sciences.
• Experience with the evolving regulatory landscape impacting AI and ML.
• Professional, confident demeanor with ability to effectively counsel and brief senior executives.
• Excellent reputation in the med-tech industry and with regulators.
• Excellent writing, communication, analysis, and partnership skills.
• Problem solver (not just an issue spotter) with creative and innovative approach along with strong decision-making abilities.
• Ability to perform in a fast-paced and continually evolving business environment.