Associate Director GRA CMC SaMD & Cybersecurity Specialist

Associate Director GRA CMC SaMD & Cybersecurity Specialist is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.Main Responsibilities and Accountabilities Support the implementation, optimization, and continuous refinement of global regulatory strategies, objectives, and policies for the Global Regulatory Affairs Device function, governing the development, registration, commercialization, and life-cycle management of the company’s global device portfolio, including SaMD/SiMD. Collaborate with cross-functional partners across Global Regulatory Affair, R&D, Quality, Global Operations, Plasma Operations, IT, and other business functions to execute regulatory strategies for a broad portfolio including plasmapheresis devices, blood establishment computer software (BECS), drug-device combination products, ancillary devices, SaMD/SiMD, mobile applications, and connected platforms. Serve as the regulatory device subject matter expert for patient-integrated care solutions initiatives, advising and facilitating alignment among diverse cross-functional stakeholders. Directly liaise, negotiate, and maintain strong, positive relationships with the US FDA, and provide oversight and guidance to regional regulatory staff in discussions with international health authorities (e.g., IMDRF regions) to enable timely decision-making, appropriate agency feedback, and rapid resolution of regulatory inquiries. Author, review, and ensure delivery of high-quality regulatory documentation—including 510(k), De Novo, PMAs, Q-Submissions/Pre-Submissions (Pre-IND, Pre-BLA), BLAs/sBLAs, MAAs, CTAs, INDs, DHFs, CE technical documentation, international device registrations, post-approval supplements and variations, MAFs, LOAs, technical files, CERs, PMCF documentation, and related briefing packages—in accordance with applicable US, EU, ISO, IEC, and IMDRF requirements. Apply expert knowledge of key ISO and IEC standards (e.g., ISO 13485, ISO 14971, ISO 10993, IEC 60601-1, IEC 62304, IEC 62366, EN ...