Vice President Regulatory Affairs Quality Assurance

Vice President of Quality Assurance and Regulatory Affairs (VP QARA) – Part-Time

Join our client’s team for 2-3 days per week. In this senior leadership role, you will be pivotal in enhancing and maintaining the Quality Management System (QMS) and ensuring the highest standards of product quality and compliance in Software as a Medical Device (SaMD) offerings. This role demands a seasoned professional with profound expertise in regulatory requirements and quality assurance practices specific to software medical devices.

Key Responsibilities:

• Develop and Implement QMS: Lead the design, implementation, and continuous improvement of the Quality Management System in compliance with ISO 13485, FDA regulations, and other applicable standards.
• Regulatory Compliance: Ensure all SaMD products meet regulatory requirements for global markets, including FDA 21 CFR Part 820 and EU MDR.
• Quality Assurance Processes: Establish and refine robust QA processes for software development, validation, and verification to maintain product quality and reliability.
• Team Leadership: Build and lead a high-performing QA and Regulatory Affairs team, fostering a culture of quality excellence and continuous improvement.
• Audit and Inspection Management: Prepare for and lead internal and external audits, ensuring readiness and compliance with all regulatory bodies.
• Risk Management: Implement and oversee risk management processes, including risk analysis, mitigation, and monitoring throughout the product lifecycle.
• Stakeholder Collaboration: Collaborate closely with cross-functional teams including R&D, product management, and regulatory affairs to align quality and regulatory objectives with business goals.
• Training and Development: Provide training and guidance on quality and regulatory standards to internal teams, ensuring a deep understanding and adherence to best practices.

Qualifications:

• Experience: Minimum of 8-10 years in Quality Assurance roles within the medical device or SaMD sector, with at least 3-5 years in a leadership position, preferably at the VP or Director level.
• Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field. An advanced degree is preferred.
• Regulatory Knowledge: In-depth understanding of FDA, ISO, and other regulatory requirements for SaMD.
• Leadership Skills: Proven track record in leading and mentoring QA and Regulatory Affairs teams in a fast-paced, innovative environment.
• Technical Expertise: Strong knowledge of the software development lifecycle (SDLC) and software validation/verification processes.
• Communication: Excellent written and verbal communication skills with the ability to effectively collaborate with both technical and non-technical stakeholders.

Application Process:

If you are interested in this part-time VP QARA opportunity, please apply directly or send your application to o.archer@x4lifesciences.com.