Remote Regulatory affairs Jobs · ISO 13485

• Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance.
• Lead the construction and execution of both formative and summative usability activities for SaMD applications
• Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability

Radformation is transforming the way cancer clinics deliver care. Their innovative software automates and standardizes radiation oncology workflows. They are a fully remote, mission-driven team united by a shared goal to reduce cancer’s global impact and help save lives.

• Support regulatory strategy and submission timelines for US market
• Own quality oversight of supplier relationships for US market
• Lead CAPA investigations and effectiveness verification

Optain is a healthcare company using software and hardware to rethink care. They aim to improve the way we detect and manage eye and systemic conditions and have a close-knit and highly talented team.

• Preparation and submission of regulatory dossiers.
• Advise on strategies and registration requirements for product development and marketed products.
• Lead regulatory assessment and actions for changes to product and QMS processes.

Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.