Senior Regulatory Affairs Lead, Software Med Devices

Abbott Laboratories; Alameda (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories seeks a Senior Regulatory Affairs Specialist for Lingo in Alameda, CA. You will support regulatory activities for Class II software medical devices, collaborating with product teams to ensure compliant submissions and labeling throughout development and post‑market stages.

The role emphasizes cross-functional leadership, regulatory strategy, and robust documentation to meet timelines and FDA requirements.

Qualifications

• Bachelor’s degree in a technical discipline required.
• Minimum 2 years regulatory experience in a regulated environment.
• Experience with 510(k)/PMA submissions or Class I/II exempt software devices preferred.
• Experience with software medical devices preferred.

Responsibilities

• Represent Regulatory Affairs on cross-functional project teams and provide strategic input on product lifecycle and regulatory requirements.
• Assess documentation for medical device submissions and communicate regulatory guidance.
• Review labeling, advertising and promotional materials for regulatory input.
• Assist with promotional content development and review for compliance.
• Lead Regulatory Affairs Ad & Promo SOP development and review.
• Prepare robust regulatory submissions to authorities and ensure post-marketing compliance.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Documentation & submissions

Communication skills

Education

Bachelor's Degree in a technical discipline

Advanced degree preferred

Job description

Abbott Laboratories seeks a Senior Regulatory Affairs Specialist for Lingo in Alameda, CA. You will support regulatory activities for Class II software medical devices, collaborating with product teams to ensure compliant submissions and labeling throughout development and post‑market stages.

The role emphasizes cross-functional leadership, regulatory strategy, and robust documentation to meet timelines and FDA requirements.