Director of Regulatory Affairs and Quality Assurance (RA / QA)

Job Description

Job Description

Position Summary

As the Director of Regulatory Affairs and Quality Assurance (RA / QA), this position is responsible for ensuring global leadership in RxFunction by influencing the creation of, and ensuring compliance with, the global regulatory requirements for the company’s emerging medical device initiatives. This position will interact with the FDA, Notified Bodies, and other regulatory authorities as needed to develop the regulatory strategies and to manage all aspects of their execution regarding RxFunction products.

This position is responsible for ensuring the overall effectiveness of the regulatory compliance program and the quality management system (QMS) throughout the organization, including its ongoing conformance with quality certification standards. It reports to the VP of Technology and works with all critical functions of the organization.

Job Responsibilities

Responsibilities include, but are not limited to, the following :

Directs and oversees the RA / QA department.

• Ensures effective staffing, wages, and professional development.
• Provides leadership, supervision, and development opportunities to direct reports.
• Verifies performance of direct reports and making fair performance decisions.
• Prepares the annual department budget in coordination with the Finance department.

Secures market approvals for RxFunction products in target geographies.

Ensures that high-quality RxFunction products are delivered to customers.

Serves as the Quality Management Representative.

Chairs the Cybersecurity Panel, which reviews and approves all cybersecurity risk assessments, mitigations, and residual risk justifications and escalations.

Maintains the highest levels of ethics and confidentiality.

Other duties and responsibilities may change or be assigned at any time with or without notice.

Required Qualifications

Preferred Qualifications