Associate Director, Regulatory Affairs (on-site)
$148,700–$297,300 year
On-site · Alameda, California, United States
Job Summary
Associate Director Regulatory Affairs will lead regulatory strategy across the product lifecycle for Abbott’s Diabetes Care portfolio, develop and communicate global regulatory plans, provide technical leadership and input on complex issues, lead and develop regulatory professionals, negotiate with regulatory authorities, ensure compliance, and oversee submission preparation, labeling reviews, and post-marketing activities. The role requires on-site work at Alameda, CA, collaboration with cross-functional teams, and a focus on advancing regulatory pathways and policies to support product development and lifecycle management.
Required Qualifications
- Bachelor's degree in a relevant field
- 5-7 years’ experience in regulated industry (medical products) or related area
- Experience with Class III US and EU submissions and SaMD (preferred)
- Strong regulatory knowledge and leadership capabilities
- Ability to work cross-functionally and manage multiple priorities
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