Regulatory Affairs Specialist - Vascular (on-site)
Abbott · Santa Clara, CA +1 more
RegulatoryFull-time$82k–$141kCompany career page
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Role summary
Abbott seeks a Regulatory Affairs Specialist for its Vascular Division to support EU and US regulatory compliance for endovascular medical devices. The role involves evaluating regulatory impact, preparing submissions, assessing product changes, and maintaining approvals for commercial products across global markets.
What they're looking for
- Bachelor's degree or equivalent
- 2-3 years regulated industry experience (medical devices, quality, R&D, or related field)
- Strong team collaboration and fast-paced matrixed environment capability
- Excellent verbal and written communication at multiple organizational levels
- Working knowledge of medical device regulations and standards
- Experience with Class II or III medical device submissions preferred
What you'll be doing
- Evaluate regulatory impact and develop global strategies for product lifecycle management
- Prepare and support regulatory submissions for vascular devices to US and EU authorities
- Assess product, manufacturing, and labeling changes for regulatory impact across markets
- Develop regulatory assessments supporting design control and change management activities
- Maintain regulatory approvals and registrations for marketed products
Privacy & handoff
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