What are the responsibilities and job description for the Quality Assurance Regulatory Affairs Manager position at Skills Alliance?
Job Title: Senior QARA Manager
Location: New Jersey
Job Type: Permanent (Full time)
A pioneering startup in the medical imaging space, revolutionizing surgery through cutting-edge technology and innovative solutions are continuing to grow and are seeing a Senior QARA Manager to lead and strengthen their QMS ensuring compliance with industry standards and regulatory requirements. Their proprietary platform integrates advanced imaging analytics, AI, and real-time 3D visualization to enhance surgical precision and efficiency.
The Senior QARA Manager will be responsible for developing, implementing, and maintaining the company’s quality management system (QMS) in accordance with medical device industry regulations. This role will ensure compliance with FDA, ISO 13485, and other applicable standards while driving continuous improvement initiatives to uphold product quality, safety, and effectiveness. The ideal candidate will have a strong background in quality assurance for medical devices, with experience in imaging technology or surgical solutions being a plus.
Responsibilities:
- Develop, implement, and maintain the company’s Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other regulatory requirements.
- Lead internal and external audits, including FDA inspections and ISO certification processes, ensuring regulatory compliance.
- Oversee risk management activities (ISO 14971) and ensure robust design control processes for new product development.
- Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Clinical Teams, to ensure quality requirements are met throughout the product lifecycle.
- Establish and monitor quality metrics, CAPA processes, non-conformance investigations, and continuous improvement initiatives.
- Drive supplier quality management, including audits, qualifications, and compliance monitoring.
- Ensure compliance with software validation requirements for medical imaging solutions and AI-driven applications.
- Provide leadership and mentorship to the quality team, fostering a culture of quality and compliance across the organization.
Requirements:
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
- 8 years of experience in quality management within the medical device industry, with a focus on imaging, software, or surgical technologies preferred.
- Strong knowledge of FDA regulations, ISO 13485, ISO 14971, MDR, and other global regulatory requirements.
- Proven success in managing audits, regulatory inspections, and compliance programs.
- Excellent leadership, problem-solving, and communication skills.
- Ability to work in a fast-paced startup environment, balancing strategic initiatives with hands-on execution.
