Regulatory Affairs Specialist II – Heart Failure (on-site)
Abbott · Pleasanton, CA
RegulatoryFull-time$82k–$141kCompany career page
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Role summary
Abbott seeks a Regulatory Affairs Specialist II to prepare and manage regulatory submissions for heart failure medical devices. The role involves developing applications for FDA and international agencies, reviewing engineering changes, and ensuring worldwide compliance with regulatory standards.
What they're looking for
- Bachelor's degree or equivalent education and work experience combination
- Minimum 2 years in regulated industry (medical devices, pharma, nutritionals, or related field)
- Strong written and verbal communication skills; ability to write and edit technical documents
- Cross-functional collaboration and ability to work in matrixed environments
- Analytical and critical thinking with meticulous attention to detail
- Experience with 510(k) applications, PMA supplements, or international medical device regulations preferred
What you'll be doing
- Prepare robust regulatory applications for FDA and international regulatory agency submissions
- Create, review, and approve engineering changes and supporting documentation
- Review regulatory guidelines and conduct project regulatory assessments
- Maintain and distribute current domestic and international medical device regulations to appropriate personnel
- Interface with FDA and regulatory agencies; support product release and GTS licensing processes
Key requirements
- Therapeutic area
- Cardiovascular
Privacy & handoff
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