Director of Quality & Regulatory Affairs for SaMD

X4 Life Sciences; United States; On-site; USD 130,000 - 180,000; Full time

Job summary

A leading digital health solutions provider is seeking an experienced Director/Senior Director of Quality & Regulatory Affairs to guide the regulatory strategy for AI-driven Software as a Medical Device (SaMD) products. The ideal candidate will have over 10 years of experience in Quality and Regulatory Affairs and a proven track record in the medical device industry, managing compliance and quality management systems to ensure product standards and safety.

Qualifications

• 10+ years of progressive experience in Quality and Regulatory Affairs within the medical device industry.
• Proven expertise in Software as a Medical Device (SaMD).
• Minimum 5 years of leadership experience managing teams.

Responsibilities

• Define and execute the company’s vision for quality and compliance.
• Lead pre-market and post-market QARA activities.
• Develop and implement regulatory strategies.

Skills

Quality Management

Regulatory Affairs

Leadership

Communication

Collaboration

Education

10+ years in Quality and Regulatory Affairs

Experience with Class I and II medical devices

Tools

ISO 13485

MDSAP

FDA regulations

Job description

A leading digital health solutions provider is seeking an experienced Director/Senior Director of Quality & Regulatory Affairs to guide the regulatory strategy for AI-driven Software as a Medical Device (SaMD) products. The ideal candidate will have over 10 years of experience in Quality and Regulatory Affairs and a proven track record in the medical device industry, managing compliance and quality management systems to ensure product standards and safety.