Global Regulatory Affairs Specialist, Intelligence

Edwards Lifesciences Gruppe; United States; Vor Ort; USD 74.000 - 104.000; Vollzeit

Benefits dieser Stelle

Competitive salaries

Performance-based incentives

Benefits programs

Zusammenfassung

Edwards Lifesciences is seeking a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs to support global regulatory compliance and cross-functional teams. The role offers opportunities for global interaction and to accelerate market access while ensuring patient safety and product quality.

The candidate will drive regulatory process improvements, monitor regulatory changes, and provide strategic guidance for worldwide regulatory requirements, including FDA

Qualifikationen

• Bachelor’s degree and minimum of 3 years of Regulatory Affairs experience in a highly regulated industry or Master’s degree with at least 1 year of Regulatory Affairs experience.
• ISO 13485:2016 knowledge or certification is preferred.
• Strong understanding of global medical device regulations, especially for Class II/III devices.

Aufgaben

• Support implementation of Regulatory process improvement projects with key stakeholders.
• Support Regulatory Intelligence and Standards Management programs to identify regulatory changes.
• Provide guidance on strategies and contingency planning for worldwide regulatory requirements.

Kenntnisse

Regulatory knowledge

Communication skills

Microsoft Office

Ausbildung

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

Microsoft Office Suite

Jobbeschreibung

Edwards Lifesciences is seeking a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs to support global regulatory compliance and cross-functional teams. The role offers opportunities for global interaction and to accelerate market access while ensuring patient safety and product quality.

The candidate will drive regulatory process improvements, monitor regulatory changes, and provide strategic guidance for worldwide regulatory requirements, including FDA