Regulatory Affairs Specialist II - Medical Devices

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

Job summary

Abbott in Alameda, CA is seeking a Regulatory Affairs Specialist II to perform specialized regulatory submissions for medical devices and guide product entries through FDA and international requirements. On-site role with cross-functional collaboration across engineering, QA, and marketing.

You will evaluate regulatory guidelines, maintain up-to-date submission systems, and support the product release process to ensure compliant, timely market entry for Abbott's Lingo platform.

Qualifications

• Bachelor’s degree (or equivalent) in a regulated industry is required.
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area preferred.
• Strong verbal and written communications with ability to communicate at multiple levels.

Responsibilities

• Prepare regulatory submissions for devices to achieve objectives.
• Review and approve engineering change orders related to documentation.
• Review regulatory guidelines and ensure compliance across global regulatory standards.
• Maintain up-to-date domestic and international medical device regulations in systems.

Skills

Regulatory knowledge

Strong communication

Team collaboration

Regulatory submissions

Education

Bachelor’s degree (or equivalent)

Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields

Master’s degree in Regulatory Affairs

Job description

Abbott in Alameda, CA is seeking a Regulatory Affairs Specialist II to perform specialized regulatory submissions for medical devices and guide product entries through FDA and international requirements. On-site role with cross-functional collaboration across engineering, QA, and marketing.

You will evaluate regulatory guidelines, maintain up-to-date submission systems, and support the product release process to ensure compliant, timely market entry for Abbott's Lingo platform.