GRA CMC SaMD & Cybersecurity Specialist – CSL – Jobs in King of Prussia, PA | OpenJobs AI

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GRA CMC SaMD & Cybersecurity Specialist

CSL

a day ago

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OnsiteFull-timeSenior

Summary

CSL is seeking a GRA CMC SaMD & Cybersecurity Specialist to join their team in King of Prussia, PA. The role involves developing and implementing global regulatory strategies for Software as a Medical Device and ensuring compliance across all regions.

About the Role

As a GRA CMC SaMD & Cybersecurity Specialist, you will be responsible for coordinating regulatory strategies for medical devices, collaborating with internal stakeholders, and serving as the primary liaison to the US FDA. Your tasks will include authoring regulatory documentation, advising on regulatory strategy, and ensuring compliance with international standards.

About You

Required:

Bachelor's degree in engineering, computer science, or a related field.
Over 5 years of experience in regulatory roles within the medical device or pharmaceutical industry.
In-depth knowledge of global device regulatory requirements including EU MDR and ISO standards.
Proven ability to generate successful FDA and international submissions.

Preferred:

Advanced degree (e.g., MS, PhD) in a relevant field.
Experience managing FDA and notified body interactions.
Familiarity with emerging digital health technologies and cybersecurity requirements.

Benefits

Comprehensive benefits package including health, dental, and vision coverage.
Opportunities for professional development and career advancement.
Supportive work environment focused on inclusion and belonging.

CSL

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

King of Prussia, PA