SaMD RA Consultant

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a SAMD Consultant to join our amazing team. 

Job Title: Freelance SaMD Consultant

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview: We are seeking a skilled and experienced freelance SAMD (Software as a Medical Device) Consultant to join our team. The ideal candidate will have a strong background in regulatory affairs, software development, and quality assurance within the medical device industry, with expertise in navigating the unique regulatory challenges associated with software-based medical devices. 

Responsibilities:

• Collaborate with clients to assess the regulatory classification and requirements for their software-based medical devices, including SAMD products intended for diagnostic, therapeutic, monitoring, or decision support purposes.
• Review and evaluate clients’ software development plans, design documentation, risk management files, and testing protocols to ensure compliance with regulatory requirements and industry standards, including FDA regulations, IEC 62304, and ISO 13485.
• Provide guidance on the development and implementation of quality management systems (QMS) specific to software-based medical devices, including software development life cycle (SDLC) processes, configuration management, and software validation and verification.
• Assist clients in preparing and assembling regulatory submissions for software-based medical devices, including premarket notifications (510(k)s), de novo submissions, premarket approval applications (PMAs), and regulatory submissions for international markets.
• Conduct regulatory assessments and gap analyses of clients’ software development processes, quality systems, and documentation to identify areas of non-compliance and opportunities for improvement.
• Coordinate with cross-functional teams, including software engineers, quality assurance specialists, regulatory affairs professionals, and clinical affairs experts, to ensure alignment and integration of regulatory requirements throughout the product development lifecycle.
• Support clients in preparing for and managing regulatory interactions, including meetings, teleconferences, and submissions to regulatory agencies and notified bodies.

Requirements:

• Bachelor’s degree in computer science, engineering, life sciences, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in regulatory affairs, quality assurance, or software development roles within the medical device industry, with a minimum of 5 years working directly with SAMD products and regulatory requirements.
• In-depth knowledge of FDA regulations governing software-based medical devices, including the FDA’s Software Precertification Program, guidance documents, and relevant consensus standards (e.g., IEC 62304, ISO 13485).
• Proven track record of successfully developing, validating, and commercializing software-based medical devices, including mobile medical apps, standalone software applications, and cloud-based solutions.