Associate Director GRA CMC SaMD & Cybersecurity Specialist

Location: King of Prussia, Pennsylvania, United States; onsite

Company

hirify.global is a global biotherapeutics company developing therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas through plasma, recombinant protein, and cell and gene therapy platforms.

What you will do

• Develop, coordinate, and implement global regulatory strategies for standalone and combination medical devices, including SaMD, SiMD, connected platforms, mobile applications, and blood establishment computer software.
• Lead device regulatory activities across development, registration, commercialization, and lifecycle management.
• Prepare, author, review, and manage submissions including 510(k)s, PMAs, De Novo requests, Q-Submissions, BLAs, MAAs, CTAs, INDs, technical files, CERs, PMCF documentation, and international registrations.
• Serve as a regulatory device subject matter expert for patient-integrated care solutions and advise R&D, Quality, IT, Global Operations, and Plasma Operations.
• Liaise and negotiate with the US FDA and provide oversight for interactions with international health authorities and notified bodies.
• Advise on design controls, cybersecurity, human factors, regulatory change control, due diligence, and global regulatory policies and procedures.

Requirements

• Bachelor’s degree in engineering, computer science, a scientific discipline, or a related field; an advanced degree is preferred.
• More than 5 years of progressive regulatory experience in the medical device, pharmaceutical, or biotechnology industry.
• Extensive knowledge of global device regulations and standards, including EU MDR, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 60601, IEC 62366, and IMDRF SaMD guidance.
• Proven experience preparing FDA, EU, and international submissions, including 513(g) requests, pre-submissions, IDEs, 510(k)s, PMAs, De Novo submissions, and EU MDR registrations.
• Experience managing FDA and notified body meetings, audits, inspections, and interactions with regional health authorities.
• Demonstrated leadership in developing high-performing regulatory device teams and influencing stakeholders in a matrixed organization.

Culture & Benefits

• Work within a global organization operating in more than 100 countries.
• Cross-functional collaboration across regulatory affairs, research and development, quality, operations, plasma operations, and IT.
• Culture centered on inclusion, belonging, curiosity, empathy, accountability, and collaboration.
• Employee benefits are provided through CSL’s benefits programs.