Associate Director, Regulatory Affairs (on-site)

Join Abbott as an Associate Director of Regulatory Affairs in our Alameda, California office. This is a full-time, on-site position where you'll drive regulatory strategy for one of the world's leading healthcare companies, shaping how our diagnostic, medical device, pharmaceutical, and nutritional products reach patients globally.

About the Role

As Associate Director of Regulatory Affairs at Abbott, you'll lead regulatory initiatives that enable our innovative healthcare solutions to serve patients in more than 160 countries. You'll work at the intersection of innovation and compliance, partnering with R&D, Quality, and Commercial teams to navigate complex regulatory landscapes and accelerate product approvals while maintaining the highest standards of compliance.

What You'll Do

• Develop and execute regulatory strategies for product submissions, amendments, and lifecycle management across therapeutic areas
• Lead interactions with regulatory bodies including the FDA and international health authorities
• Oversee technical documentation, regulatory filings, and compliance submissions
• Advise cross-functional teams on regulatory requirements and best practices for medical devices, diagnostics, and pharmaceutical products
• Monitor regulatory trends, policy changes, and competitive landscapes to identify opportunities and risks
• Mentor and guide regulatory professionals within your team and across functions
• Ensure all activities comply with applicable regulations, quality standards, and Abbott policies

What We're Looking For

• Bachelor's degree required; advanced degree in regulatory affairs, life sciences, or related field preferred
• 7+ years of regulatory affairs experience in the medical device, diagnostic, or pharmaceutical industry
• Demonstrated knowledge of FDA regulations, international regulatory frameworks, and compliance requirements
• Proven leadership experience with the ability to influence cross-functional teams
• Strong written and verbal communication skills with the ability to translate complex regulations into actionable guidance
• Experience managing regulatory submissions and navigating pre-market approval processes
• Strategic thinking with attention to detail and commitment to regulatory excellence

About Abbott

Abbott is a global healthcare leader with a diverse portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines. Our 115,000+ colleagues are dedicated to helping people live more fully at every stage of life, serving diverse healthcare needs across more than 160 countries. At Abbott, you'll contribute to life-changing innovations in a collaborative, impact-driven environment.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.