Regulatory Affairs Specialist II – Heart Failure (on-site)
Abbott · Pleasanton, CA
RegulatoryFull-time$86k–$156kCompany career page
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Role summary
Abbott seeks a Regulatory Affairs Specialist II to support cardiovascular product development and regulatory submissions for the Heart Failure business unit. The role involves preparing US regulatory documentation, managing product lifecycle compliance, and collaborating with cross-functional teams in Pleasanton, California.
What they're looking for
- Bachelor's degree or equivalent education and work experience
- 5 years of professional work experience
- Medical device industry experience preferred
- 1-2 years of regulatory affairs experience preferred
- 510(k), PMA, or international regulatory submission experience preferred
- RAPS Certification preferred
- Strong written and verbal communication skills
What you'll be doing
- Execute and verify regulatory requirements for product development, submissions, and lifecycle maintenance
- Develop and implement global regulatory strategies throughout product development and planning
- Prepare US regulatory submissions and registration documents with supervisory review
- Anticipate regulatory obstacles and collaborate on solutions with regulatory and cross-functional teams
- Lead functional groups in gathering data for regulatory submissions and support approval processes
Key requirements
- Therapeutic area
- Cardiovascular
Privacy & handoff
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