Regulatory Affairs Manager: Diabetes Care Devices

Regulatory Jobs; Alameda, Milpitas, Austin (CA, CA, TX); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education assistance

Job summary

Abbott is seeking a Regulatory Affairs Manager for an onsite role based in Alameda, CA (also Milpitas, CA or Austin, TX). The role leads regulatory strategy, mentors a team, and partners with R&D, clinical, quality and commercial teams to bring innovative diabetes care products to market.

Responsibilities include driving FDA pathways, preparing submissions, and ensuring compliance across the product lifecycle while maintaining speed to market.

Qualifications

• Bachelor's Degree in a related field or equivalent experience.
• 4+ years in a regulated industry; 2–5 years in regulatory preferred.
• Ability to communicate effectively with diverse audiences.
• Experience with domestic and international regulatory guidelines.

Responsibilities

• Lead U.S. regulatory strategy for new products and lifecycle management.
• Mentor and develop a team of regulatory professionals.
• Collaborate with R&D, clinical, quality, and commercial teams to influence development.
• Provide guidance on FDA pathways, submissions (510(k), PMA) and post-market activities.
• Interact with regulatory authorities to ensure timely approvals and compliance.

Skills

Regulatory strategy

Team leadership

FDA submissions

Effective communication

Regulatory guidelines

Education

Bachelor's degree in related field

Job description

Abbott is seeking a Regulatory Affairs Manager for an onsite role based in Alameda, CA (also Milpitas, CA or Austin, TX). The role leads regulatory strategy, mentors a team, and partners with R&D, clinical, quality and commercial teams to bring innovative diabetes care products to market.

Responsibilities include driving FDA pathways, preparing submissions, and ensuring compliance across the product lifecycle while maintaining speed to market.