Regulatory Affairs Specialist II, Structural Heart

Abbott; California; On-site; USD 82,000 - 141,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement plan with high-em

Tuition reimbursement and education

Diversity and inclusion programs

Global career development

Job summary

Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Santa Clara, CA, focusing on regulatory submissions for structural heart devices. You will contribute to FDA and international filings, ensure labeling accuracy, and collaborate with engineering and quality teams.

The role requires strong regulatory knowledge, 3+ years of experience, and the ability to operate in a fast-paced, global environment. Abbott offers comprehensive benefits and career development opportunities.

Qualifications

• Bachelor’s Degree or equivalent.
• Minimum 3 years’ related experience, including at least 2 years regulatory experience.
• Experience with 510(k), IDE supplements, PMA supplements or EU/intl medical device regs.
• Ability to work in a team and as an individual contributor in a fast-paced environment.
• Strong problem-solving and communication skills; able to adapt to changing priorities.

Responsibilities

• Prepare robust regulatory applications for FDA and international regulators.
• Review and approve engineering changes and device labeling.
• Interface with FDA and other regulatory agencies as needed.
• Support regulatory activities for clinical trials and product market entry.
• Maintain up-to-date knowledge of domestic/international medical device regulations and submissions.

Skills

Regulatory knowledge

Verbal & written communication

Team contribution

Problem solving

Adaptability

Education

Bachelor’s Degree or equivalent (Regulatory or Science)

Master’s degree (preferred)

Science/Technical discipline

Job description

Abbott is seeking a Regulatory Affairs Specialist II to work on-site in Santa Clara, CA, focusing on regulatory submissions for structural heart devices. You will contribute to FDA and international filings, ensure labeling accuracy, and collaborate with engineering and quality teams.

The role requires strong regulatory knowledge, 3+ years of experience, and the ability to operate in a fast-paced, global environment. Abbott offers comprehensive benefits and career development opportunities.