Regulatory Affairs Specialist II — Med Devices (Onsite)

Abbott; Alameda (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Alameda, CA seeks a Regulatory Affairs Specialist II to perform specialized regulatory submissions and ensure product compliance with FDA and international standards. You will prepare documentation for regulatory registration and support market entry for medical devices on site.

You will review change orders, evaluate communications for regulatory accuracy, maintain current regulations in submission systems, and collaborate with Regulatory Operations, marketing, and QA to enable timely

Qualifications

• Bachelor’s degree (or equivalent) required.
• 2–3 years in a regulated industry (medical products preferred).
• Ability to work in a fast-paced, matrixed team.
• Strong verbal and written communication across multiple levels.

Responsibilities

• Prepare regulatory submissions for medical devices to meet regulatory objectives.
• Review engineering change orders and related documentation for new and sustaining projects.
• Act as regulatory representative for guidelines compliance.
• Evaluate communications to ensure FDA and global regulatory standards are met.
• Maintain up-to-date domestic and international device regulations in the submission systems.
• Support product release by coordinating with Regulatory Operations to ensure timely compliance.
• Collaborate with marketing to review advertising and promotional materials.
• Assist with QMS, EMS, and other regulatory requirements.

Skills

Communication skills

Team collaboration

Regulatory knowledge

Education

Bachelor’s degree

Master’s degree in Regulatory Affairs

Job description

Abbott in Alameda, CA seeks a Regulatory Affairs Specialist II to perform specialized regulatory submissions and ensure product compliance with FDA and international standards. You will prepare documentation for regulatory registration and support market entry for medical devices on site.

You will review change orders, evaluate communications for regulatory accuracy, maintain current regulations in submission systems, and collaborate with Regulatory Operations, marketing, and QA to enable timely