Remote Regulatory Submission Lead – EU IVDR/CE for IVDs

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.Verifichi qui sotto se possiede i requisiti...

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure evidence supports claims, align labeling, and coordinate with internal teams and external consultants to maintain compliance throughout the product lifecycle. The role requires EU IVDR experience,...

Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company. Mira’s breakthrough innovation was creating the market’s only FDA-compliant at-home hormone monitor with quantitative testing technology....

Overview In this Regulatory Affairs Lead role, you shape IVD regulatory strategies, guiding performance evaluation and marketing authorizations. You will act as the regulatory lead for global project teams, coordinating interactions with authorities and ensuring compliant submissions. The role supports lifecycle management and continuous improvement within...

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and...