Regulatory Affairs Specialist II
Abbott · New Brighton, MN
RegulatoryFull-time$61k–$123kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Abbott seeks a Regulatory Affairs Specialist II to support product development and regulatory approvals for transcatheter aortic valve devices in the Structural Heart division. The role involves providing regulatory guidance across cross-functional teams, preparing submissions for investigational and commercial approval, and managing postmarket compliance activities.
What they're looking for
- Bachelor's degree or equivalent education and industry experience
- 3-4 years experience in regulated industry such as medical devices
- 2-3 years regulatory, quality assurance, or related field experience
- Strong written and verbal communication skills with regulatory agencies
- Ability to work in matrixed, geographically diverse environments
- Knowledge of medical device regulatory requirements and submission processes
- Master's degree in Regulatory Affairs preferred
What you'll be doing
- Provide regulatory guidance and strategic input to cross-functional product development teams
- Assess quality, preclinical, and clinical documentation; compile and submit regulatory filings
- Develop and update regional regulatory strategy in response to regulatory changes
- Monitor regulatory applications and changing regulations; submit required postmarket reports
- Evaluate preclinical, clinical, and manufacturing changes for regulatory filing implications
Privacy & handoff
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