RA Manager, Heart Valves

Job Title: Regulatory Affairs Manager, Heart Valves

Location: Irvine, CA (REMOTE)
Reports To: Senior Manager, Regulatory Affairs

Position Summary

The Project Manager, Regulatory Affairs is responsible for the preparation, coordination, and submission of global regulatory documentation to support medical device development and commercialization. This role ensures submissions are scientifically sound, compliant, and delivered on time while supporting regulatory strategy across the product lifecycle.

This individual partners cross-functionally with teams such as R&D, Quality, Clinical, Manufacturing, and Marketing to translate regulatory requirements into actionable plans and ensure alignment with global standards.

Key Responsibilities

• Prepare and submit high-quality regulatory documentation, including investigational applications, commercial registrations, supplements, and annual reports
• Serve as a core regulatory representative on product development and sustaining teams, providing strategic guidance to meet global regulatory requirements
• Collaborate with cross-functional stakeholders to develop technical, clinical, and labeling documentation for submissions
• Support global regulatory communications, including interactions with regulatory authorities, distributors, and external partners
• Review engineering and quality documentation (e.g., change orders, FMEAs, protocols, CAPAs) for regulatory impact
• Manage and interpret global regulatory standards and requirements to support product development and compliance
• Contribute to post-market activities including adverse event reporting (MDRs, vigilance), complaint analysis, and field safety actions
• Provide mentorship and guidance to junior regulatory staff as needed
• Support internal and external audits and maintain regulatory procedures and documentation systems

Qualifications

Required:

• Bachelor's degree in engineering, biology, or related scientific discipline
• 5-8 years of experience in medical device Regulatory Affairs
• Strong knowledge of global regulatory frameworks, quality systems, and product development processes
• Proven ability to interpret regulatory standards and guide cross-functional teams
• Experience with regulatory submissions and compliance documentation

Preferred:

• Experience with US Class III cardiovascular devices
• Familiarity with EU MDR implementation

Skills & Competencies

• Strong technical writing, communication, and organizational skills
• Ability to manage multiple projects in a fast-paced environment
• Analytical problem-solving and sound decision-making
• Self-directed with the ability to work independently and collaboratively
• Adaptability to changing priorities and regulatory landscapes
• High level of professionalism, diplomacy, and cross-cultural awareness
• Proficiency with Microsoft Office Suite

Additional Requirements

• Cannot support sponsorship
• Ability to occasionally lift or move up to 20 pounds