Director, Regulatory Affairs - San Diego, CA

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 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 ...

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 ...

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. · ...

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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 ...

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

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 ...

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. · ...

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

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 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 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 ...

This is an exciting position to join a world leader at the forefront of healthcare innovation. With a global footprint, the Director will support US and Global regulatory strategy and submissions for their flagship product. · We are looking for successful regulatory professionals ...

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

Provide regulatory support and expertise associated with US and global submission requirements. · ...

We are seeking an experienced Regulatory Affairs Director to lead our global regulatory strategy for in vitro diagnostics (IVDs). · Bachelor's degree in Life Sciences or a related discipline required; advanced degree strongly preferred. · 12+ years of experience in Regulatory Aff ...

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 ...

Regulatory Affairs Associate II role requires a strong understanding of FDA and EU regulations, with experience in preparing regulatory submissions and obtaining approvals. · ...

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