Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k) - Monmouth Junction, NJ

We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development. · ...

We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development. · Bachelor's degree in related field. · 5+ years regulatory/quality experience. · ...

We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development. · Lead preparation and submission of FDA 510(k) applications. · Coordinate CROs and external consultants. · ...

This role leads the planning and operational execution of regulated laboratory activities that enable precision medicine with a major focus on Companion Diagnostics (CDx) design control validation clinical enablement. · ...

This role leads planning operational execution regulated laboratory activities enabling precision medicine major focus Companion Diagnostics CDx design control validation clinical enablement agility pivot GLP bioanalysis PKPDADA under GxP principles when program needs require it. ...

This role leads the planning and operational execution of regulated laboratory activities that enable precision medicine with a major focus on Companion Diagnostics CDx design control validation and clinical enablement · ...

+ Working at Bristol Myers Squibb is anything but usual + Challenging meaningful life-changing those aren't words that are usually associated with a job + But working here uniquely interesting work happens every day in every department + From optimizing a production line to the l ...

+ Develop and implement global regulatory strategies for in vitro diagnostic technologies + Collaborate with cross-functional teams to navigate complex regulatory landscapes + Optimize product development and directly influence the success of product approvals through strategic n ...

The Global Regulatory Affairs (GRA) Device team supports medical device combination product digital health and in-vitro diagnostic products within Sanofi portfolio products.The GRA Device organization serves as critical strategic partner within Sanofi's regulatory framework provi ...

We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, · safe,and effective technologies that can transform cancer care.The role assists with regulatory strategy and the development of submissions in partnership with key i ...

We are seeking a GRA Device Associate to join our team in the Global Regulatory Affairs (GRA) Device Digital and Diagnostic team. As a key member of this team, you will contribute to global regulatory strategies for in-vitro diagnostic technologies and collaborate with cross-func ...

We're looking for a Device Associate to join our Global Regulatory Affairs (GRA) team. As a Device Associate, you'll contribute to global regulatory strategies for in-vitro diagnostic technologies and collaborate with cross-functional teams to navigate complex regulatory landscap ...

+Job summary · Lensas ayudamos a encontrar puestos laborales en los Estados Unidos · +ResponsibilitiesDesarrolla estrategias regulatorias y planes de actividades para posicionarse óptimamente frente al FDA globalmente. · ...

We are seeking a transformational leader to drive QuidelOrtho's Quality organization into a digitally enabled, insight-driven function. This role is accountable for governance of quality IT platforms, data strategy, and end-to-end data analytics that empower smarter decisions, op ...