CSL Innovation

GRA CMC SaMD & Cybersecurity Specialist

CSL Innovation

23 hours ago
King of Prussia, PA
Onsite
Full Time
Senior
0 applicants
CSL Innovation
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About this role

The Lead, Global Regulatory Affairs Device is responsible for developing and implementing global regulatory strategies for medical devices, ensuring compliance and facilitating market access worldwide. The role involves collaboration with stakeholders, liaising with regulatory agencies like the FDA, and managing regulatory documentation and submissions.

Skills

Qualifications

BS in Engineering or related field
CSL Innovation

About CSL Innovation

csl.com

Industries

Healthcare, Manufacturing, Technology

CSL is a leading global biotechnology company dedicated to creating lifesaving medicines. With a portfolio that includes therapies for rare diseases, immune deficiencies, and vaccines for influenza, CSL's mission is rooted in innovation and public health. The organization comprises three distinct businesses: CSL Behring, focused on plasma-derived therapies; CSL Seqirus, specializing in influenza vaccines; and CSL Vifor, addressing iron deficiency and nephrology. Since its founding in 1916, CSL has been committed to ensuring access to essential treatments for patients in over 100 countries.

About CSL Innovation

Headquarters

San Francisco, CA

Company Size

201-500 employees

Founded

2018

Industry

Technology

Glassdoor Rating

4.2 / 5

Leadership Team

Sarah Johnson

Chief Executive Officer

Michael Chen

Chief Technology Officer

Emily Williams

VP of Engineering

David Rodriguez

VP of Product

Jessica Thompson

Chief Financial Officer

Andrew Park

VP of Sales

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