Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors Expert

Job DescriptionWe are seeking a highly experienced Senior Director to lead our Regulatory Platform for CMC and Device-Drug Combinations. As a key member of our team, you will be responsible for developing and implementing innovative regulatory strategies to ensure the successful launch of our products.Key Responsibilities:Develop and implement regulatory...

Job DescriptionTakeda Pharmaceutical is seeking a highly skilled Technical Regulatory Advisor GRA CMC, Drug-Device Combinations US to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative device and integral/co-packaged combination product regulatory strategies for development, registration,...

About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.We are seeking a highly experienced Senior Director to lead our GRA CMC Pharmaceuticals Development Portfolio team.Key Responsibilities:Establish collaboration with Global...

Job DescriptionAt Takeda Pharmaceutical, we are a forward-thinking organization that unlocks innovation and delivers transformative therapies to patients worldwide.We are seeking a highly skilled Technical Regulatory Advisor to join our team in the United States. As a key member of our regulatory team, you will be responsible for developing and implementing...

About the RoleTakeda Pharmaceuticals is seeking a highly experienced Senior Director to lead our CMC Pharmaceutical Development Portfolio. As a key member of our Regulatory Affairs team, you will be responsible for establishing collaboration with Global CMC teams and leadership, enabling CMC regulatory team's success in meeting goals and objectives.Key...

Job Title: Human Factors Principal ConsultantAt PA Consulting, we are seeking a highly skilled Human Factors Principal Consultant to join our team in Boston. As a key member of our Human Factors Engineering group, you will work alongside a wide range of medical device and pharmaceutical companies to provide expert HF consulting services.Key...

Job Title: Human Factors Principal ConsultantWe are seeking a highly skilled Human Factors Principal Consultant to join our team in Boston. As a key member of our Human Factors Engineering group, you will partner with clients to provide expert consulting services, including usability engineering, HF regulatory strategy, and generative, formative, validation,...

Unlock Human Performance with WHOOPAt WHOOP, we're on a mission to empower our members to perform at a higher level through a deeper understanding of their bodies and daily lives. As a Senior Human Factors Researcher, you will play a critical role in helping us achieve this mission.Key Responsibilities:Lead human factors studies for regulated features,...

Human Factors Engineer OpportunityWe are seeking a talented Human Factors Engineer to support the development of medical devices at one of our clients in Boston, MA.Key Responsibilities:Apply human factors methodologies to design human-machine systems and medical devices.Develop and implement research methodologies to test and evaluate new concepts and...

Human Factors Engineer OpportunityWe are seeking a talented Human Factors Engineer to support the development of medical devices at one of our clients in Boston, MA.Key Responsibilities:Apply human factors methodologies to design human-machine systems and medical devices.Develop and implement research methodologies to test and evaluate new concepts and...

Job SummaryThe Chemistry Manufacturing Controls Associate Director at Vertex is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. The Associate Director provides...

Job Title: Human Factors Principal ConsultantWe are seeking a highly skilled Human Factors Principal Consultant to join our team in Boston. As a key member of our Human Factors Engineering group, you will be responsible for providing expert consulting services to our clients in the medical device and pharmaceutical industries.About the RoleThis is an...

Job Title: Human Factors Principal ConsultantWe are seeking a highly skilled Human Factors Principal Consultant to join our team in Boston. As a key member of our Human Factors Engineering group, you will be responsible for providing expert consulting services to our clients in the medical device and pharmaceutical industries.About the RoleThis is a hands-on...

About the Role:Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.We are seeking a highly experienced Director, Regulatory Affairs CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration...

{"Responsibilities": "Key ResponsibilitiesLead human factors studies for regulated features, including formative and summative testingWork with the Regulatory Affairs team to ensure test documentation meets necessary reporting standards for regulatory submissionsCoach other researchers on human factors best practices, including training additional study...

About the RoleWe are seeking a highly skilled Senior Human Factors Design Engineer to join our team at Medtronic. As a key member of our Surgical Robotics Organization, you will play a critical role in executing human factors efforts within the System Architecture Center of Excellence.Key ResponsibilitiesLead Human Factors projects supporting business...

Job DescriptionGradient, a Geosyntec Company, is seeking a Senior Medical Device Toxicologist to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. You will have the opportunity to work with our team of experts in environmental sciences, human and ecological risk sciences, product...

Job DescriptionThe Chemistry Manufacturing Controls Associate Director plays a pivotal role in executing global regulatory CMC strategies for investigational and marketed products. This position leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. Additionally, this role provides...

Job Title: Associate Director, Chemistry Manufacturing ControlsJob Summary:The Associate Director, Chemistry Manufacturing Controls, plays a critical role in executing global regulatory CMC strategies for investigational and marketed products. This position leads the preparation and filing of regulatory CMC submissions and manages interactions with Health...

Job Title: CMC Expert - BiologicsLocation: Hybrid (NJ, Boston)Job Description:We are seeking a highly skilled CMC Expert specializing in Biologics to provide regulatory and lifecycle management support for a large client. This role is instrumental in fulfilling client needs for regulatory submissions, ensuring compliance with post-approval processes, and...