Remote Regulatory Affairs Project Leader

Jenavalve Technology Inc; Irvine (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Jenavalve Technology Inc. seeks an experienced Senior Manager, Regulatory Affairs to lead global submissions for clinical and post-market activities, coordinate cross‑functional teams, and ensure timely, compliant regulatory deliverables.

You will interact with regulatory bodies, distributors, and teams across R&D, manufacturing, and quality to translate complex requirements into practical plans. You will mentor staff, review risk assessments and change controls, and support MDR/vigilance

Qualifications

• Bachelor’s degree in a scientific field required.
• 5–8 years in medical device Regulatory Affairs.
• Experience with US Class III cardiovascular devices preferred.
• Knowledge of EU MDR and global regulatory requirements.

Responsibilities

• Prepare regulatory submissions for global devices.
• Interact with internal teams and regulatory agencies.
• Lead audits and maintain procedures.
• Support adverse event reporting and vigilance activities.

Skills

Regulatory submissions

Project management

Technical writing

Regulatory affairs

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Job description

Jenavalve Technology Inc. seeks an experienced Senior Manager, Regulatory Affairs to lead global submissions for clinical and post-market activities, coordinate cross‑functional teams, and ensure timely, compliant regulatory deliverables.

You will interact with regulatory bodies, distributors, and teams across R&D, manufacturing, and quality to translate complex requirements into practical plans. You will mentor staff, review risk assessments and change controls, and support MDR/vigilance