Senior Regulatory Affairs Specialist - Digital Health Technologies (On-Site)
Location: Alameda, CA / Milpitas, CA
Category: Regulatory Affairs
About Abbott:
Abbott is a global healthcare leader committed to improving lives through innovative technologies in diagnostics, medical devices, nutritionals, and branded medicines. With 114,000 employees across 160+ countries, Abbott offers an environment for career growth, learning, and meaningful impact.
Why Join Abbott?
Career development opportunities with a global leader.
Free medical coverage through the Health Investment Plan (HIP) PPO medical plan.
Competitive retirement savings plan with high employer contributions.
Tuition reimbursement and student debt programs for career advancement.
A recognized workplace for diversity, working mothers, and executive leadership.
Named one of the world's most admired companies by Fortune.
The Opportunity
Abbott’s Diabetes Care Division in Alameda, CA or Milpitas, CA is seeking a Senior Regulatory Affairs Specialist to support the development and commercialization of digital health technologies, including AI-driven solutions. The role involves working with cross-functional teams to ensure compliance with regulatory requirements for Class II software medical devices.
Key Responsibilities:
Provide regulatory input to product design and development teams.
Support software development and systems engineering teams with regulatory guidance.
Develop and maintain Regulatory Affairs SOPs for next-generation products.
Prepare and review regulatory submissions (e.g., 510(k), PMA) for approval.
Assess and document regulatory implications of product changes and labeling updates.
Ensure compliance with post-marketing regulatory requirements.
Evaluate insulin dosing algorithms, AI/ML technologies, and digital health solutions.
Provide strategic guidance on regulatory planning and lifecycle management.
Mentor and support less experienced regulatory staff.
Qualifications:
Required:
Bachelor’s degree in a technical field (e.g., Biology, Chemistry, Medical Technology).
Minimum 2 years of regulatory experience or 2+ years of relevant industry experience in quality, product development, or scientific affairs.
Preferred:
Advanced degree in Engineering, Sciences, or a related discipline.
Experience with 510(k) / PMA submissions for medical devices.
Knowledge of insulin dosing products and diabetes management solutions.
Experience with SaMD, AI/ML, and digital health technologies.
Familiarity with Predetermined Change Control Plans (PCCPs).
4-6 years of experience in a regulated industry.
Strong cross-functional collaboration, multitasking, and communication skills.
Understanding of FDA QSR regulations and regulatory impact assessments.
Base Pay Range: $86,700 – $173,300 (varies by location).
For more details on Abbott's benefits, visit: www.abbottbenefits.com
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