Regulatory Affairs Specialist II — Structural Heart

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

Benefits offered by this job

Free medical coverage (HIP PPO)

Strong retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott seeks a Regulatory Affairs Specialist II to perform specialized regulatory activities for a transcatheter heart valve replacement device, on-site at the Santa Clara, CA location. The role includes preparing regulatory submissions, ensuring compliance with FDA and international regulations, and supporting clinical trials and market entry.

You will review and input on labeling, manage regulatory documentation, and interact with FDA and other agencies as needed, contributing to a robust

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 either 510(k) applications, IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.

Responsibilities

• Prepares robust regulatory applications to achieve departmental objectives (FDA or international).
• Creates, reviews and approves engineering changes.
• Reviews device labeling for regulatory compliance.
• Interprets regulatory guidelines and provides project regulatory assessments as needed.
• Maintains domestic and international medical device regulations in submission data bases and files.

Skills

Regulatory experience

Regulatory submissions

Strong communication

Team collaboration

Education

Bachelor’s degree

Master’s degree

Job description

Abbott seeks a Regulatory Affairs Specialist II to perform specialized regulatory activities for a transcatheter heart valve replacement device, on-site at the Santa Clara, CA location. The role includes preparing regulatory submissions, ensuring compliance with FDA and international regulations, and supporting clinical trials and market entry.

You will review and input on labeling, manage regulatory documentation, and interact with FDA and other agencies as needed, contributing to a robust