Associate Director GRA CMC SaMD & Cybersecurity Specialist

Job overview

The Associate Director GRA CMC SaMD & Cybersecurity Specialist is an onsite full-time role based in King of Prussia, PA. This position is responsible for developing and implementing global regulatory strategies for Software as a Medical Device (SaMD) and combination products. CSL is a global biotechnology leader focused on patient-integrated care solutions. The role exists to ensure worldwide regulatory compliance and market access for the company's device portfolio. It contributes to the company's strategic objectives by collaborating with cross-functional teams and liaising with health authorities like the US FDA.

What you'll do

• Develop and implement global regulatory strategies for SaMD and medical devices.
• Ensure worldwide regulatory compliance and market access.
• Serve as primary liaison to the US FDA for device matters.
• Author and review high-quality regulatory documentation (510(k), PMA, BLA, etc.).
• Apply expert knowledge of ISO and IEC standards.
• Advise on regulatory strategy, design control, and cybersecurity requirements.
• Perform regulatory assessments for acquisitions and partnerships.

What we're looking for

Skills & competencies

full-time

day shift

king of prussia pa

csl

regulatory affairs

samd

cybersecurity

biotech

medical devices

fda

onsite

Work arrangement

• Weekend coverage required

Benefits & perks

• Competitive compensation, comprehensive benefits package, opportunities for professional growth.

Why this role

Specialized role focusing on SaMD, cybersecurity, and global regulatory strategy for medical devices.

About the employer

CSL is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.