Regulatory Affairs Specialist

Job SummaryThe Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Werfen's Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing...

Job SummaryThe Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Werfen's Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing...

Job DescriptionCompany OverviewSPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design, and marketing of advanced consumer diagnostic products.We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.Job SummaryWe are seeking a highly skilled Regulatory...

Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on regulatory...

Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on regulatory...

About WerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.Our BusinessOur business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics,...

About WerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.Our BusinessOur business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics,...

Job DescriptionCompany OverviewSPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design, and marketing of advanced consumer diagnostic products.We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.Job SummaryWe are seeking a highly skilled Regulatory...

Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on...

Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on...

Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a deep understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international standards.Key...

Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a deep understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international standards.Key...

Part-Time Regulatory Compliance Specialist Brayson Consulting Ltd is currently seeking a part-time Regulatory Compliance Specialist to support our client's new care service. This role is ideal for an individual looking to advance their career towards a full-time Registered Manager position in the future. The Regulatory Compliance Specialist will possess...

Part-Time Regulatory Compliance Specialist Brayson Consulting Ltd is looking for a dedicated part-time Regulatory Compliance Specialist to support our client's new care service. This role is ideal for someone with a background as a Registered Manager who is interested in potential future advancement to a full-time managerial position. The Regulatory...

Part-Time Regulatory Compliance Specialist Brayson Consulting Ltd is looking for a dedicated part-time Regulatory Compliance Specialist to oversee compliance within a new care service. The ideal candidate will possess prior experience as a Registered Manager and will play a crucial role in ensuring adherence to all regulatory standards. Key...

Part-Time Regulatory Compliance Specialist Brayson Consulting Ltd is currently seeking a part-time Regulatory Compliance Specialist to oversee compliance within a new care service. This role is ideal for an individual with prior experience as a Registered Manager, who may aspire to transition into a full-time managerial position in the future. The primary...

Part-Time Regulatory Compliance Specialist Brayson Consulting Ltd is looking for a dedicated part-time Regulatory Compliance Specialist to oversee adherence to industry regulations within the healthcare sector. The ideal candidate will possess prior experience as a Registered Manager and will play a crucial role in ensuring that all operational practices...

PART TIME REGULATORY COMPLIANCE SPECIALISTBrayson Consulting Ltd is looking for a part-time Regulatory Compliance Specialist to join our team. This role is ideal for someone with aspirations to advance to a full-time managerial position in the future. The successful candidate will possess prior experience in a managerial capacity and will be tasked with...

Position Overview:The individual will be accountable for overseeing the registration and renewal procedures with the China NMPA and Japan PMDA for IL-labeled products. This role necessitates close collaboration with design and risk management teams, formulating regulatory strategies for new and modified products, maintaining Technical Files, and ensuring...

OverviewWerfenWerfen is a leading global company in the specialized diagnostics industry, with a strong presence in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our innovative approach and commitment to quality have enabled us to become a worldwide leader in our field. With a global footprint of over 30 countries and a...