Senior Regulatory Affairs Specialist, Global Medical Devices

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

JenaValve Technology, Inc. seeks a Senior Specialist, Regulatory Affairs to manage global regulatory submissions, collaborate with cross-functional teams, and ensure compliance for medical devices in the Irvine, CA office.

This role supports post-market surveillance, adverse event reporting, and regulatory strategy. The candidate will interact with regulatory authorities, prepare submissions, and help translate complex regulations into actionable plans while maintaining quality system alignment

Qualifications

• Experience applying global medical device regulations and product development processes.
• Comprehensive knowledge of quality systems and their relation to business.
• Ability to interpret regulatory standards and guide project teams.

Responsibilities

• Lead preparation, submission, and maintenance of global filings for regulatory approvals and registrations.
• Serve as regulatory team member in product development and sustaining teams.
• Interpret regulatory requirements related to labeling, studies, testing, and recordkeeping.

Skills

Regulatory Affairs

Medical Devices

Regulatory Strategy

Technical Writing

Cross-functional Collaboration

Project Management

Quality Systems

Education

Bachelor's degree in a scientific discipline

Job description

JenaValve Technology, Inc. seeks a Senior Specialist, Regulatory Affairs to manage global regulatory submissions, collaborate with cross-functional teams, and ensure compliance for medical devices in the Irvine, CA office.

This role supports post-market surveillance, adverse event reporting, and regulatory strategy. The candidate will interact with regulatory authorities, prepare submissions, and help translate complex regulations into actionable plans while maintaining quality system alignment