Global Regulatory Affairs Director, Medical Devices

Jenavalve Technology; Irvine (CA); On-site; USD 245,000 - 265,000; Full time

Job summary

Jenavalve Technology in Irvine, CA, is seeking a Senior Director of Global Regulatory Affairs to lead global submissions and drive early approvals for medical devices. You will manage the RA team, translate regulatory requirements into practical plans, and coordinate with US and international regulators, legal agents, and partners.

The role requires 10–15 years in Class III medical device regulatory affairs plus a bachelor's degree in a scientific field.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 10–15 years in Class III medical device regulatory affairs and/or quality and/or product development.
• Experience managing personnel and project teams.
• Comprehensive knowledge of global medical device regulations and quality systems.
• Ability to interpret regulatory standards and guidance to guide project teams.

Responsibilities

• Directs and oversees the Regulatory Affairs department and processes.
• Prepare high‑quality global filings for regulatory submissions and amendments.
• Manage RA staff, develop procedures, and ensure timely submissions.
• Oversee communication with regulators, distributors, and internal teams.
• Lead regulatory team support for product development and sustaining work.
• Identify and interpret external standards; drive closure of gaps.
• Review marketing materials for regulatory compliance.
• Review risk management activities, test protocols, NCRs, CAPAs, and DCOs.

Skills

Regulatory strategy

Global regulatory affairs

Project management

Leadership & people management

Communication

Technical writing

Regulatory compliance

Negotiation

Risk assessment

Education

Bachelor's degree in a scientific discipline

Job description

Jenavalve Technology in Irvine, CA, is seeking a Senior Director of Global Regulatory Affairs to lead global submissions and drive early approvals for medical devices. You will manage the RA team, translate regulatory requirements into practical plans, and coordinate with US and international regulators, legal agents, and partners.

The role requires 10–15 years in Class III medical device regulatory affairs plus a bachelor's degree in a scientific field.