Associate Director, Regulatory Affairs - San Diego

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. · ...

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. · ...

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 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. · ...

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 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 ...

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 ...

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. · ...

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 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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The job is for a Regulatory Affairs Associate who will provide regulatory support and expertise associated with US and global submission requirements. The associate will analyze requirements, track deliverables, and execute global regulatory strategies. · ...

Regulatory Affairs Associate II role requires a strong understanding of FDA and EU regulations, with experience in 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 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 ...

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 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 ...

· Who is CorDx?   · CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care me ...

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

The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera. · ...

Provide regulatory support and expertise associated with US and global submission requirements. · Drives projects forward and executes agreed upon strategies and plans with oversight. · Maintains awareness of applicable regulations. · ...