Global Regulatory Submissions Lead, Medical Devices

kozmetickesluzby.vecnakraska.sk - Jobboard; Irvine (CA); On-site; USD 90,000 - 127,000; Full time

Benefits offered by this job

Performance-based incentives

Variety of benefits programs

Job summary

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.

Qualifications

• Minimum of 5 years of experience in regulatory affairs.
• Preparation of domestic and international product submissions.

Responsibilities

• Provide input on regulatory requirements for product development teams.
• Prepare documentation for submission to global regulatory agencies.
• Monitor global regulations and assess their impact on projects.

Skills

Regulatory requirements knowledge

Excellent written and verbal communication

Problem-solving skills

Regulatory compliance expertise

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.