Senior Regulatory Affairs – Software Medical Devices

Abbott; California; On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Excellent retirement plan with high-em

FreeU education benefit

Job summary

Abbott is seeking a Senior Regulatory Affairs Specialist for the Lingo program in Alameda, CA. The role focuses on providing regulatory input on product development, guiding cross-functional teams, and preparing robust regulatory submissions to meet program timelines.

You will work on Class II software medical devices, ensure labeling and promotional materials compliance, and contribute to post-market regulatory activities.

Qualifications

• Bachelor’s Degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• Minimum 2 yrs. regulatory experience and/or 2 years relevant industrial experience in quality, product-development/support, scientific affairs function.

Responsibilities

• Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
• Assist with regulatory submissions to authorities and ensure documentation supports program objectives and timelines.
• Review labeling, advertising and promotional materials for regulatory compliance with Marketing teams.
• Assist in SOP development and review to support next-gen product offerings.
• Evaluate regulatory impact of design changes and implement required actions.
• Ensure compliance with post-marketing regulatory requirements.

Skills

Regulatory knowledge

Cross-functional collaboration

Regulatory strategy

Documentation planning

Education

Bachelor’s Degree in biology/chemistry/biomedical

Advanced degree in Engineering/Sciences

Job description

Abbott is seeking a Senior Regulatory Affairs Specialist for the Lingo program in Alameda, CA. The role focuses on providing regulatory input on product development, guiding cross-functional teams, and preparing robust regulatory submissions to meet program timelines.

You will work on Class II software medical devices, ensure labeling and promotional materials compliance, and contribute to post-market regulatory activities.