Monitors all safety aspects of clinical research trials.
Collects, assesses and processes Adverse Events (SAE) for safety reporting.
Prepares narratives of adverse events for adjudication by the CEC.
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. At Cordis, teammates bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives.
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.
Liaise with regulatory authorities on technical/regulatory questions.
Provide technical expertise to the global Medical Devices network.
Manage the team of IVDR product assessors and IVDR IHC.
SGS stands as the world's foremost testing, inspection, and certification company, recognized globally for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we foster a dynamic, international culture committed to high professional standards and long-term employee development.
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.
You will function as a central knowledge holder in a specialized team within Pharma Regulations & Audits.
You will carry out audits and compliance checks, formulate improvement measures and supervise the implementation.
You will implement projects to improve compliance and quality processes.
Redcare Pharmacy is Europe’s leading online pharmacy driven by innovative technologies and the passion of its employees. The company strives for an inspiring and collaborative work environment where everyone feels valued and contributes to their mission: “Until every human has their health.”
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.