Senior Regulatory Affairs Specialist - Medical Devices

Regulatory Jobs; Alameda (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

HIP PPO health coverage

Excellent retirement savings plan with

Tuition reimbursement

FreeU education benefit

Recognition as a great place to work

Job summary

Abbott's Lingo team in Alameda, CA seeks a Senior Regulatory Affairs Specialist to support product development and regulatory activities for US commercialization of Class II software medical devices.

You will provide regulatory input to design and development teams, review labeling and promotional materials for compliance, prepare robust regulatory submissions, and help maintain post-market regulatory requirements across the product lifecycle.

Qualifications

• Bachelor's degree in a technical discipline.
• Minimum 2 years regulatory experience.
• Advanced degree preferred.
• 4–6 years in regulated industry preferred.
• Experience with 510(k)/PMA submissions or class I/II software devices.
• Strong cross-functional collaboration and problem solving.

Responsibilities

• Represent Regulatory Affairs on cross-functional project teams.
• Assess documentation for medical device submissions.
• Review labeling and promotional materials for compliance.
• Lead SOP development for ads and promotions.
• Prepare regulatory submissions to regulatory authorities.
• Support post-market regulatory requirements.
• Provide regulatory input to design and development teams.

Skills

Regulatory knowledge

Communication skills

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree in Engineering/Sciences

Job description

Abbott's Lingo team in Alameda, CA seeks a Senior Regulatory Affairs Specialist to support product development and regulatory activities for US commercialization of Class II software medical devices.

You will provide regulatory input to design and development teams, review labeling and promotional materials for compliance, prepare robust regulatory submissions, and help maintain post-market regulatory requirements across the product lifecycle.