Lead and manage technical functions for all medical schemes, globally.
Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements.
Drive continuous improvement of technical workflows and quality management processes.
SGS is the world's leading testing, inspection, and certification company, recognized as the global benchmark for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we enable a better, safer, and more interconnected world.
Act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR).
Partner closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams.
Help build and strengthen Docplanner's regulatory framework, directly supporting EU MDR compliance and global expansion.
Docplanner Group's mission is to help people live longer, healthier lives. As the world’s largest healthcare platform, they connect 24 million patients with 280k doctors across 13 countries. Docplanner's marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently.
Provide leadership for overall Medical Affairs and Clinical Affairs teams.
Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required.
Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory bodies.
Waters Corporation is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. Through a shared culture of relentless innovation, their passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
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.