Global Regulatory Submissions Lead, Medical Devices

kozmetickesluzby.vecnakraska.sk - Jobboard; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Extensive benefits

Job summary

Edwards Lifesciences in Irvine, CA seeks a Senior Specialist in Regulatory Affairs to support product development with regulatory input and strategy. The role emphasizes ensuring timely, compliant global submissions and maintaining rigorous documentation practices.

The ideal candidate has 5+ years of regulatory affairs experience and a Bachelor's degree in a related field. The company offers competitive salaries and extensive benefits as part of a mission-driven medical devices team.

Qualifications

• Bachelor’s degree in a related field.
• 5+ years of regulatory affairs experience.
• Experience with global submissions.

Responsibilities

• Provide regulatory input on product development.
• Oversee documentation for global submissions.
• Ensure compliance with regulatory standards.

Skills

Regulatory Affairs

Documentation

Global submissions

Compliance

Education

Bachelor's degree

Job description

Edwards Lifesciences is seeking a Senior Specialist in Regulatory Affairs to join their team in Irvine, CA. This role involves providing regulatory input on product development, overseeing documentation for global submission, and ensuring compliance with regulatory standards. The successful candidate will have at least 5 years of relevant experience and a Bachelor's Degree.

You'll be part of a mission-driven organization focused on improving patients' lives through innovative medical devices. Competitive salaries and extensive benefits programs are available.