Director, Regulatory Affairs - Advertising, Promotional and Labeling (Diagnostics)

Location: Hybrid role based in Sunnyvale, California, United States; at least 40% or 16 hours of the work week must be onsite.

Company

hirify.global develops diagnostic products and operates in the medical diagnostics and biotechnology space.

What you will do

• Lead Regulatory Affairs representation on the Promotional Materials Review Committee and ensure promotional materials meet global regulatory requirements.
• Define compliant regulatory strategies for complex, business-critical advertising and promotional concepts while mitigating portfolio-level risk.
• Oversee product claims and ensure scientifically robust, compliant messaging.
• Develop SOPs and a strategic framework for advertising and promotion governance and continuous improvement.
• Partner with senior and executive leadership to align business objectives with regulatory requirements and guide portfolio decisions.
• Support cross-functional initiatives, new technologies, and evolving organizational priorities.

Requirements

• Advanced degree in molecular biology, genomics, or diagnostics; a PhD is preferred.
• 15+ years of relevant regulatory affairs or related industry experience, or 12+ years with a master's degree or 8+ years with a PhD.
• Regulatory affairs experience in medical devices, clinical laboratories, and/or diagnostics.
• Proven success leading cross-functional teams through complex promotional regulatory challenges.
• Strong knowledge of global regulations, guidance, and standards related to advertising and promotion.
• Exceptional communication, influencing, leadership, negotiation, and executive presentation skills.

Nice to have

• Experience supporting product promotion and launches.
• Advanced proficiency with regulatory systems, submission tools such as eCTD, and enterprise compliance platforms.
• Experience leading complex programs and portfolio-level decision-making.
• Commitment to developing talent and building long-term organizational capability.

Culture & Benefits

• Flexible time off or vacation.
• 401(k) retirement plan with employer match.
• Medical, dental, and vision coverage.
• Mindfulness programs.
• Annual bonus and/or incentive compensation may be available according to applicable plans and company discretion.