Regulatory Affairs Specialist II Heart Failure Innovations

Regulatory Jobs; Pleasanton (CA); On-site; USD 86,000 - 156,000; Full time

Job summary

Abbott in Pleasanton, CA is seeking a Regulatory Affairs Specialist II to join our Heart Failure regulatory team on-site. You will apply regulatory knowledge to support product teams and prepare US regulatory submissions, while maintaining quality systems and labeling accuracy.

You will lead regulatory strategy development, analyze regulatory outcomes, and collaborate with cross-functional teams to ensure timely approvals and compliance across product lifecycles.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience.
• 5 years’ work experience.
• Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.

Responsibilities

• Verifies regulatory requirements in relation to product development, submissions, maintenance and project plans.
• Provide technical leadership and strategic input on regulatory issues.
• Develop global regulatory strategies for product development and planning.
• Lead data gathering to complete a regulatory submission.
• Follows GMP guidelines and procedures.
• Writes clear, audience-appropriate submission documents.

Skills

Regulatory knowledge

Regulatory submissions

Communication skills

Analytical thinking

Problem solving

Education

Bachelor’s degree

Technical discipline degree

Job description

Abbott in Pleasanton, CA is seeking a Regulatory Affairs Specialist II to join our Heart Failure regulatory team on-site. You will apply regulatory knowledge to support product teams and prepare US regulatory submissions, while maintaining quality systems and labeling accuracy.

You will lead regulatory strategy development, analyze regulatory outcomes, and collaborate with cross-functional teams to ensure timely approvals and compliance across product lifecycles.