QARA Director

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

Empowering Digital Health & Medical Device Organizations Across the US | Quality Assurance, Regulatory Affairs, Engineering

Director / Senior Director, Quality & Regulatory Affairs – Digital Health

An industry leader in AI-powered digital health solutions is seeking an accomplished Director or Senior Director of Quality & Regulatory Affairs (QARA) to guide the quality and regulatory strategy for a cutting-edge portfolio of Software as a Medical Device (SaMD) products.

The company provides AI-driven solutions for chronic disease management. Their platform offers personalized, real‑time coaching and connected experiences to empower individuals in managing various chronic conditions.

The Opportunity

As Director / Senior Director of QARA, you’ll play a pivotal role in ensuring the highest standards of product quality, compliance, and safety while driving the regulatory strategy to support global market expansion. You will lead a talented team across Quality Assurance and Regulatory Affairs functions, oversee the Quality Management System (QMS), and maintain compliance with international medical device regulations and standards.

Key Responsibilities

• Define and execute the company’s long‑term vision for quality and compliance across all SaMD programs.
• Lead both pre‑market and post‑market QARA activities, ensuring adherence to ISO 13485, MDSAP, and applicable global regulations.
• Maintain, enhance, and scale the Quality Management System (QMS) to meet evolving product and business needs.
• Oversee design controls, risk management, CAPA, supplier quality, complaint handling, and internal auditing processes.
• Use data‑driven insights and quality metrics to drive continuous improvement initiatives and operational excellence.
• Serve as the Management Representative for the ISO 13485‑certified QMS, reporting performance and improvement recommendations to executive leadership.

Regulatory Affairs

• Develop and implement regulatory strategies that enable timely market access for SaMD products across key geographies (U.S., EU, Canada, Japan, Australia, etc.).
• Ensure ongoing compliance with FDA, MDR/CE marking, and MDSAP requirements.
• Oversee preparation, submission, and maintenance of regulatory filings including 510(k), Technical Files, and related documentation.
• Monitor evolving global regulations, standards, and guidance documents, providing proactive recommendations to leadership.
• Partner with cross‑functional teams — including Clinical, Product, and Engineering — to embed regulatory requirements early in the product lifecycle.
• Lead regulatory inspections and act as the primary point of contact for regulatory authorities and notified bodies.

Cross-Functional & Strategic Influence

• Collaborate with Product, Engineering, and Clinical teams to integrate quality and regulatory strategy into product development and lifecycle management.
• Provide regulatory and quality input into corporate strategy, ensuring compliance and risk considerations are embedded in business decisions.
• Build and mentor a high‑performing QARA team, fostering a culture of accountability, collaboration, and continuous learning.
• Manage external quality and regulatory partners to ensure alignment with company standards and expectations.

Qualifications & Experience

• 10+ years of progressive experience in Quality and Regulatory Affairs within the medical device industry, including Class I and II devices.
• Proven expertise in Software as a Medical Device (SaMD) and software‑based regulatory pathways.
• Minimum 5 years of leadership experience, managing teams and complex compliance programs.
• Strong working knowledge of ISO 13485, MDSAP, FDA QSR, and EU MDR.
• Familiarity with ISO 14971, IEC 62304, IEC 62366, and cybersecurity standards.
• Experience leading regulatory submissions (e.g., 510(k), CE marking, MDR Technical Files) and interacting with regulatory agencies or notified bodies.
• Demonstrated success building or scaling QMS frameworks in fast‑paced, growth‑oriented environments.
• Ability to translate complex regulatory and quality requirements into practical business processes and training.
• Excellent communication, leadership, and stakeholder management skills. Experience working in an ISO 13485, MDSAP, and HITRUST‑compliant environment is highly desirable.

If you are interested, and would like to find out more, please contact me at [e-mail].