777 results for Regulatory Affairs Manager Jobs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 co...

Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially availab...

Responsible for providing regulatory input to product lifecycle planning, preparing regulatory applications for FDA and international agencies, supporting clinical strategy and submissions, and ensuring compliance with US and global post-marketing requirements. The role involves negotiation with reg...

Responsibilities With increasing independence, you will support other Development team members with project and/or process administrative tasks of low complexity. Your responsibilities include, but are not limited to, supporting project communications, conducting follow-up with project team members...

Responsible for developing and executing regulatory strategies for medical devices, providing strategic decisions on risk management, establishing relationships with health authorities, and influencing regulatory landscape. Tasks include regulatory submissions, monitoring trends, supporting global s...

Responsible for regulatory support for new product development, sustaining, and clinical study projects. Implements regulatory strategies, manages submissions, partners with Clinical Affairs, reviews device labeling, provides training, and supervises staff.

Manage a team of regulatory specialists overseeing the Diabetes Care product portfolio in the APAC region. Develop regulatory strategies, represent Regulatory Affairs on project teams, compile and prepare regulatory submissions, evaluate design changes for regulatory impact, and ensure compliance wi...

DescriptionEvery day, we work together for what matters – bold, swift, and equitable climate action.About The RoleShape the future of decarbonization policy! At 3Degrees, a leading B Corp in the environmental commodities market, we're on a mission to empower organizations to achieve a sustainable fu...

What you'll do:Develop and implement CMC regulatory strategies for investigational and marketed products to ensure successful regulatory submissions and approvals.Author or review CMC sections of regulatory submissions (INDs/CTAs, BLAs/ NDAs/MAAs, IND amendment/IMPD modification, supplements/variati...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Com...