Regulatory Affairs Specialist II - Medical Devices

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

Job summary

Abbott in Santa Clara, CA, is seeking a Regulatory Affairs Specialist II to perform regulatory activities for a transcatheter heart valve device. You will work onsite, preparing submissions for FDA and international agencies, supporting clinical trials, and ensuring compliance across regions.

The role requires a Bachelor’s degree and at least 3 years of regulatory experience, with strong communication, organization, and teamwork skills. Master’s degree and regulatory certifications are a plus.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience.
• Minimum 3 years’ related experience, including regulatory experience.
• Experience with 510(k) applications, IDE supplements, PMA supplements or EU/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, communication and organizational skills.

Responsibilities

• Prepares robust regulatory applications for FDA and international agencies.
• Creates, reviews and approves engineering changes.
• Reviews and provides input on device labeling.
• Acts as a core team member reviewing regulatory guidelines and assessments.
• Reviews communications to ensure regulatory compliance and clarity for global affiliates.
• Maintains up-to-date domestic and international medical device regulations in submission systems.
• Interface with FDA and other regulatory agencies as needed.
• Supports product release by creating licenses or approving release requests.
• Reviews protocols and reports to support regulatory submissions.
• Supports Quality Management Systems, EMS, and other regulatory requirements.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory knowledge

Attention to detail

Education

Bachelor’s Degree

Master’s degree (preferred)

Job description

Abbott in Santa Clara, CA, is seeking a Regulatory Affairs Specialist II to perform regulatory activities for a transcatheter heart valve device. You will work onsite, preparing submissions for FDA and international agencies, supporting clinical trials, and ensuring compliance across regions.

The role requires a Bachelor’s degree and at least 3 years of regulatory experience, with strong communication, organization, and teamwork skills. Master’s degree and regulatory certifications are a plus.