Regulatory Affairs Specialist II - Medical Devices

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

Job summary

Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Santa Clara, CA, focusing on regulatory activities for a transcatheter heart valve device within Structural Heart. The role supports clinical trials and market entry with robust documentation and international regulatory alignment.

You will prepare submissions, review labeling, and ensure compliance with FDA and global regulations while collaborating with multiple internal teams.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience.
• Minimum 3 years’ related experience, including a minimum of two years regulatory experience
• Experience with 510(k) applications, IDE supplements, PMA supplements and US device regulations or EU and other international medical device regulations and submissions
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Strong problem-solving skills and ability to think strategically and see the big picture
• Adaptable with the ability to switch priorities and accomplish all tasks
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Strong organizational and follow-up skills, as well as attention to detail
• Multitasks, prioritizes and meets deadlines in timely manner.

Responsibilities

• Prepares robust regulatory applications to achieve departmental goals (FDA or international).
• Creates, reviews and approves engineering changes.
• Reviews and provides input on device labeling.
• Acts as core team member reviewing applicable regulatory guidelines and assessments.
• Reviews communications to ensure detail and regulatory compliance across global affiliates.
• Maintains domestic and international regulations in submission data bases and files.
• May interface directly with FDA and other regulatory agencies.
• Supports product release by creating licenses or reviewing release requests.
• Reviews protocols and reports to support regulatory submissions.
• Complies with FDA and international regulations and company procedures.

Skills

Regulatory docs

FDA submissions

Communication skills

Team collaboration

Education

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Tools

Regulatory databases

Job description

Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Santa Clara, CA, focusing on regulatory activities for a transcatheter heart valve device within Structural Heart. The role supports clinical trials and market entry with robust documentation and international regulatory alignment.

You will prepare submissions, review labeling, and ensure compliance with FDA and global regulations while collaborating with multiple internal teams.