Senior International Regulatory Affairs Specialist - Structural Heart (on-site)

Abbott seeks a Senior International Regulatory Affairs Specialist for its Structural Heart division in Santa Clara. The role involves managing global regulatory submissions, developing submission strategies, and ensuring compliance across international markets for medical device registration and post-market activities.

Responsibilities

• Manage preparation and submission of global regulatory filings for sustaining changes and new product registrations
• Develop and update regional regulatory strategies based on regulatory changes and outcomes
• Assess quality, preclinical, and clinical documentation for submission acceptability
• Monitor regulatory applications under review and submit applicable reports to authorities
• Maintain registrations, licenses, and post-market compliance requirements

Requirements

• Bachelor's degree in related field or equivalent education and work experience
• 3-4 years experience in regulated industry such as medical devices or nutritionals
• 2-3 years regulatory affairs experience; quality assurance, R&D, or scientific affairs considered
• Strong verbal and written communication skills
• Ability to negotiate with regulatory agencies internally and externally
• Experience managing rest-of-world or international regulatory submissions