Director, CMC Regulatory Affairs - San Diego

We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. · Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject. · 2–4 years of Regulatory Affairs e ...

Direct medical device regulatory experience with recent hands-on EU MDR 2017/745 experience and ISO 13485 familiarity. · Bachelor's Degree in pharmacy, biology, chemistry, pharmacology or related subject. · RAC Certification preferred. · ...

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. · ...

We are seeking a Regulatory Affairs Associate II with hands-on medical device regulatory experience to support U.S. and global submissions. · Prepare and manage U.S. and global regulatory submissions (FDA, EU MDR) · Support change assessments and regulatory impact analyses ...

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We are seeking a detail-oriented Regulatory Affairs Specialist to support US and global medical device submissions. · Prepare and manage global regulatory submissions and registration dossiers. · Ensure compliance with FDA, EU MDR, and worldwide regulatory requirements. · ...

The Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to support RA efforts for Dexcom's software products and components. · ...

The Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to support RA efforts for Dexcom's software products and components. · ...

This role supports execution of global regulatory strategies and preparation and maintenance of registration dossiers for U.S. and global medical device submissions. · ...

This is an exciting opportunity to join our team as a Regulatory Affairs Associate II in San Diego, CA. As a key member of our team, you will be responsible for preparing regulatory submissions and obtaining approvals. · ...

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. · We've already changed millions of lives and we're ready to ch ...

Provide regulatory support and expertise associated with US and global submission requirements. · Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject. · ...

Provide regulatory support and expertise associated with US and global submission requirements including analysis of the requirements and tracking of deliverables. Assures full regulatory compliance of all documentation for submissions and change management to enable product appr ...

+Provide regulatory support and expertise associated with US and global submission requirements. · Drives projects forward and executes agreed upon strategies and plans with oversight. · ...

The Regulatory Affairs Specialist will work within Regulatory Affairs and with cross-functional teams to support RA efforts for Dexcom's software products and components.Dexcom began as a small company with a big dream: To forever change how diabetes is managed. · ...

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products. · ...

Pacira BioSciences busca un interno para su equipo de Asuntos Regulatorios. El candidato ayudará con proyectos relacionados con la implementación de iniciativas basadas en inteligencia artificial (AI) dentro del equipo. Será una oportunidad ideal para estudiantes universitarios o ...

The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera.This position involves planning, preparing, authoring and/or reviewing documents for inclusion in regulatory submissions, · including medical w ...

The Regulatory Affairs Intern will work alongside the Regulatory Affairs Department to gain knowledge and insight into the group and how it fits into the company from a domestic and global standpoint. · The Regulatory Affairs department plays a vital role in ensuring compliance w ...

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products. · Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required. · Master's degree preferred. · ...

The Regulatory Affairs Manager will support the preparation, review and submission of regulatory documentation for medical device products ensuring compliance with applicable regulations including FDA ISO 13485 and other global standards This position collaborates with cross func ...