Senior Regulatory Affairs Lead - Global MDR & Submissions

Jenavalve Technology Inc; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Jenavalve Technology Inc. in Irvine, CA is seeking a Sr. Manager of Regulatory Affairs to lead global filing strategy, develop submissions, and negotiate with regulatory authorities for both US and EU.

The ideal candidate brings 7–10 years in medical device regulatory affairs, deep knowledge of EU MDR, US IDE/PMA submissions, and strong leadership to guide cross-functional teams toward compliant products. You will mentor staff, maintain quality systems, review labeling and marketing content, and

Qualifications

• 7–10 years in medical device regulatory affairs.
• Experience with EU MDR implementation.
• US IDE/PMA submissions experience.
• Experience with cardiovascular devices and transcatheter heart valves preferred.
• Comprehensive knowledge of quality systems.

Responsibilities

• Lead preparation of US and EU regulatory filings for registrations, reports, and amendments.
• Serve as regulatory lead for JenaValve transition to EU MDR.
• Develop filing strategy and negotiate with regulatory authorities.
• Collaborate with cross-functional teams to translate requirements into submissions.
• Coach and develop direct reports; conduct internal audits as needed.
• Review marketing materials for regulatory compliance.
• Support adverse event reporting and vigilance activities.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Technical writing

Project management

Interagency liaison

Education

Bachelor’s degree in a scientific discipline (engineering, biology, etc.)

Master’s degree or equivalent

Job description

Jenavalve Technology Inc. in Irvine, CA is seeking a Sr. Manager of Regulatory Affairs to lead global filing strategy, develop submissions, and negotiate with regulatory authorities for both US and EU.

The ideal candidate brings 7–10 years in medical device regulatory affairs, deep knowledge of EU MDR, US IDE/PMA submissions, and strong leadership to guide cross-functional teams toward compliant products. You will mentor staff, maintain quality systems, review labeling and marketing content, and