Associate Director GRA CMC SaMD & Cybersecurity Specialist
Employment type
Full-time
Work setting
On-site
Location
King of Prussia, PA
Schedule
Day shift
Posted
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Job overview
The Associate Director works onsite in King of Prussia, PA, developing global regulatory strategies for Software as a Medical Device (SaMD) and cybersecurity. Compensation is not specified in the posting. CSL Behring is a global biotherapeutics leader dedicated to saving lives. This role exists to ensure worldwide regulatory compliance and market access for the company's device portfolio. The Associate Director contributes to the organization by serving as a subject matter expert and liaison to health authorities.
What you'll do
- Develop global regulatory strategies
- liaise with US FDA
- ensure compliance with ISO/IEC standards
- author regulatory documentation
- advise on cybersecurity requirements.
What we're looking for
- Skills & competencies
- full-timeday shiftking of prussia pacsl behringregulatory affairssamdcybersecurityonsiteno on-callno travelbiotech
- Work arrangement
- Weekend coverage required
Benefits & perks
- Comprehensive benefits package
- Well-being programs
- Inclusion and belonging initiatives.
Why this role
Focus on SaMD and cybersecurity; requires extensive regulatory experience.
About the employer
CSL Behring is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.
Additional details
- Industry sector
- 32
- Industry
- Pharmaceutical Preparation Manufacturing
- Occupation code
- 11-9199.00
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Listing ID: f6c31b1a-dd94-4ea1-a30d-f3cddfa93fb3