Director of Quality Assurance and Regulatory Affairs

Reports to: VP of Regulatory, Compliance and Assay Commercialization

Position Overview: We are seeking an experienced and motivated Quality Assurance/Regulatory Affairs (QA/RA) Leader to join our dynamic team. The successful candidate will be responsible for leading the QA/RA function, implementing a Quality Management System, ensuring compliance with regulatory requirements, and driving a culture of continuous improvement in quality processes throughout the organization.

Key Responsibilities:

1. Quality Management System (QMS) Leadership:

• Develop, author, implement, and maintain an effective QMS in accordance with relevant regulatory standards (FDA, ISO 13485 etc.).
• Oversee and manage quality processes, including document control, change control, CAPA, and internal audits.

1. Regulatory Affairs:

• Stay abreast of global regulatory requirements for IVD products and ensure the company's products comply with applicable regulations.
• Prepare and submit regulatory filings, such as 510(k) submissions, to regulatory authorities.
• Act as the primary contact for regulatory agencies and manage communications during inspections or audits.

1. Quality Assurance:

• Lead and conduct internal and external audits to assess compliance with regulatory standards and company procedures.
• Collaborate with cross-functional teams to establish and maintain quality objectives and key performance indicators.
• Drive the development and execution of training programs to ensure employees understand and adhere to quality processes.

1. Product Lifecycle Management:

• Provide QA/RA oversight throughout the product lifecycle, from product development to post-market surveillance.
• Collaborate with R&D and manufacturing teams to ensure new products meet regulatory and quality requirements.

1. Risk Management:

• Implement and maintain a robust risk management process for products, processes, and the overall business.

Qualifications:

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
• Minimum of 10 years of experience in QA/RA leadership roles within the IVD industry.
• In-depth knowledge of global regulatory requirements for IVD products that include immunoassays, hardware, firmware, and software.
• Proven experience with successful regulatory submissions and interactions with regulatory agencies.
• Strong leadership skills with the ability to influence and drive a culture of quality throughout the organization.
• Excellent communication and interpersonal skills.

SiPhox is an innovative in-vitro diagnostic (IVD) company dedicated to advancing healthcare through cutting-edge diagnostic solutions for use at home. We are developing a novel platform and a extensive menu of tests in microfluidic cartridges. We plan to manufacture and distribute globally.

Our Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.