Regulatory Affairs Lead, Medical Devices Global Submissions

MicroPort; Irvine (CA); On-site; USD 125,000 - 145,000; Full time

Benefits offered by this job

Competitive medical, dental, and vision insurance

401K with employer matching

Paid holidays and PTO

Job summary

A leading medical device company in Irvine, CA is seeking a Project Manager for Vertical Marketing and Regulatory Affairs. The role involves managing regulatory compliance processes, leading global submissions, and overseeing project operations. Candidates should have 5-8 years of regulatory experience in the medical device industry, preferably with supervisory experience. Excellent benefits, including competitive insurance and a 401K plan, are offered.

Qualifications

• Minimum 5-8 years of experience in regulatory affairs within the medical device industry.
• 1–3 years of supervisory or managerial experience preferred.
• Demonstrated ability to lead cross-functional projects.

Responsibilities

• Manage regulatory affairs for assigned programs ensuring compliance.
• Lead preparation and submission of regulatory documentation.
• Manage departmental milestones, timelines, and budgets.

Skills

U.S. FDA regulations

Regulatory affairs experience

Leadership

Communication skills

Project management

Education

Bachelor’s degree in life sciences, engineering, or regulatory affairs

Master’s or PhD

Job description

A leading medical device company in Irvine, CA is seeking a Project Manager for Vertical Marketing and Regulatory Affairs. The role involves managing regulatory compliance processes, leading global submissions, and overseeing project operations. Candidates should have 5-8 years of regulatory experience in the medical device industry, preferably with supervisory experience. Excellent benefits, including competitive insurance and a 401K plan, are offered.