Regulatory Affairs Specialist II - Structural Heart Devices

Abbott (abbottcareers2 board); Santa Clara (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan with high employer_con

Tuition reimbursement

Job summary

Abbott Structural Heart regulatory affairs specialist position in Santa Clara, CA. This role focuses on preparing and submitting regulatory documentation to FDA and international agencies, ensuring compliance across product lifecycles.

On-site work at our Santa Clara location supports clinical trials and market entry efforts. The ideal candidate has a minimum of three years in regulatory affairs, with experience in 510(k)/PMA processes or EU regulations, and strong communication to coordinate

Qualifications

• Bachelor's degree or equivalent education/work experience.
• Minimum 3 years' related regulatory experience.
• Experience with either 510(k), IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations.

Responsibilities

• Prepare regulatory submissions for FDA and international agencies.
• Review device labeling and engineering changes for compliance.
• Interface with FDA and other regulatory bodies as needed.
• Support product release and QA systems compliance.
• Maintain up-to-date regulatory knowledge across regions.

Skills

Regulatory experience

FDA guidelines

Regulatory submissions

Team collaboration

Strong communication

Education

Bachelor's degree

Job description

Abbott Structural Heart regulatory affairs specialist position in Santa Clara, CA. This role focuses on preparing and submitting regulatory documentation to FDA and international agencies, ensuring compliance across product lifecycles.

On-site work at our Santa Clara location supports clinical trials and market entry efforts. The ideal candidate has a minimum of three years in regulatory affairs, with experience in 510(k)/PMA processes or EU regulations, and strong communication to coordinate