Regulatory Affairs Specialist II (Medical Devices)

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 join on-site. The role involves preparing regulatory submissions, reviewing engineering changes, and ensuring compliance with FDA and international regulations.

You will collaborate with marketing and cross-functional teams to support product launches and lifecycle activities. The position requires 2–3 years in a regulated industry, a Bachelor’s degree, and strong communication skills.

Qualifications

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

Responsibilities

• Prepare regulatory submissions for devices to meet department objectives.
• Review and approve engineering change orders and related documentation.
• Act as regulatory representative for applicable guidelines (FDA and international).
• Maintain up-to-date domestic and international medical device regulations.
• Collaborate with marketing to review advertising and promotional materials.

Skills

Regulatory knowledge

Communication skills

Teamwork

Adaptability

Education

Bachelor's degree

Job description

Abbott in Alameda, CA seeks a Regulatory Affairs Specialist II to join on-site. The role involves preparing regulatory submissions, reviewing engineering changes, and ensuring compliance with FDA and international regulations.

You will collaborate with marketing and cross-functional teams to support product launches and lifecycle activities. The position requires 2–3 years in a regulated industry, a Bachelor’s degree, and strong communication skills.