Senior Regulatory Affairs Specialist

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

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

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 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...

Job Summary:Werfen is seeking a highly skilled Regulatory Affairs Specialist to join our team. 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 regulatory...

Job Summary:Werfen is seeking a highly skilled Regulatory Affairs Specialist to join our team. 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 regulatory...

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 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...

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...

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...

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...