Global Regulatory Affairs Lead

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

JenaValve Technology, Inc. is seeking a Sr. Manager of Regulatory Affairs to lead global filings and strategy for EU MDR and US submissions. The role requires coordinating with product teams and external regulators to ensure timely, compliant filings across regions.

The position emphasizes leadership of a regulatory group, interfacing with agencies, and advancing device approvals while integrating risk management and quality-system knowledge into strategic plans.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 7–10 years in medical device Regulatory Affairs.
• 2 years of direct management experience.
• Experience with EU MDR implementation.
• Experience with US Class III, IDE submissions and/or PMA submissions.
• Experience with cardiovascular devices and transcatheter heart valves preferred.
• Comprehensive knowledge of quality systems.
• Ability to interpret regulatory standards and guidance and provide direction to project teams.

Responsibilities

• Prepare high-quality US and EU filings for regulatory submissions and amendments.
• Contribute regulatory strategy to product development and quality system projects.
• Collaborate with stakeholders to develop technical, clinical, or labeling content.
• Coach and support direct reports and regulatory team members.
• Communicate with regulatory bodies, legal agents, distributors, and suppliers.
• Review changes to ensure filings are compliant across regions.
• Interpret regulatory requirements for products, labeling, and studies.
• Review marketing materials for regulatory compliance.
• Support adverse event reporting and MDRs.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Project management

Regulatory writing

Communication

Quality systems

Education

Bachelor’s degree in a scientific discipline

Job description

JenaValve Technology, Inc. is seeking a Sr. Manager of Regulatory Affairs to lead global filings and strategy for EU MDR and US submissions. The role requires coordinating with product teams and external regulators to ensure timely, compliant filings across regions.

The position emphasizes leadership of a regulatory group, interfacing with agencies, and advancing device approvals while integrating risk management and quality-system knowledge into strategic plans.