Executive VP, Quality & Regulatory Affairs

Nihon Kohden North America, Inc.; Irvine (CA); Sur place; USD 215 000 - 300 000; Plein temps

Avantages offerts par ce poste

Perks & Benefits

Résumé du poste

Nihon Kohden America seeks a strategic leader to serve as Vice President of Quality Assurance & Regulatory Affairs. You will guide QA, RA, compliance, and Quality Systems, and partner with NKC to align regulatory, quality, and post-market activities with business goals.

You will lead the QMS, regulatory submissions, and audits, while building a high-performing team and driving continuous improvement across the product lifecycle and customer-facing operations.

Qualifications

• 15+ years of progressive Quality Assurance and Regulatory Affairs experience within the medical device industry.
• 10+ years of people management experience, leading teams or projects, and providing training.
• Extensive knowledge of FDA regulations, 21 CFR Part 820, ISO 13485 requirements, and Health Canada Medical Device Regulations.
• Demonstrated success leading FDA inspections and ISO 13485 surveillance and recertification audits.
• Ability to balance regulatory compliance requirements with commercial business objectives.

Responsabilités

• Establishes and executes QA and Regulatory Affairs strategies that support business growth, customer satisfaction, product lifecycle management, and operational excellence.
• Leads the QMS leadership and provides executive oversight for CAPA, complaint handling, document control, change control, supplier quality, risk management, and management review processes.
• Develops regulatory strategies supporting product registrations, market access, product modifications, software releases, and lifecycle management within the US and Canada.
• Serves as primary liaison with NKC and collaborates with NKC Quality, Regulatory, Clinical, Engineering, and Product Development teams to ensure efficient, compliant actions.
• Maintains audit readiness and directs responses to audit findings and regulatory observations.

Connaissances

FDA inspections

ISO 13485

Regulatory affairs

CAPA

Quality management systems

Leadership and people management

Risk management

Cross-functional collaboration

Formation

Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or related technical discipline

Description du poste

Nihon Kohden America seeks a strategic leader to serve as Vice President of Quality Assurance & Regulatory Affairs. You will guide QA, RA, compliance, and Quality Systems, and partner with NKC to align regulatory, quality, and post-market activities with business goals.

You will lead the QMS, regulatory submissions, and audits, while building a high-performing team and driving continuous improvement across the product lifecycle and customer-facing operations.