Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist

The Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist is responsible for: 

• Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for  plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary 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, 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 of regulatory strategies, objectives, and policies for the Global Regulatory Affairs Device function. This includes defining and optimizing regulatory strategies, objectives, and policies that govern and support the development, registration, commercialization, and life-cycle management of CSL’s global device portfolio.  
• Collaborate with cross-functional colleagues in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions to execute assigned activities within global regulatory device strategies for CSL’s medical device portfolio, including plasmapheresis devices, drug-device combination products, standalone drug delivery devices, and ancillary devices.  
• Directly liaise and negotiate with the US FDA and oversee and advise regional regulatory staff on discussions with international health authorities and agencies for device-related matters during development and commercial use. Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management. 
• Author and review high-quality, compliant regulatory documents (e.g., 510(k), De Novo, PMAs, technical documentation for CE mark application, initial BLAs and MAAs, international device registrations, post-approval variations/supplements, INDs, CTAs, DHFs, Q-submissions, MAFs and other relevant regulatory filings such as meeting requests and briefing packages) based on relevant US, EU, and ISO standards for the device portfolio within defined timelines as per R&D and commercial objectives. 
• Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for device-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements. 
• Advise on regulatory device strategies, solutions to engineering problems and interpretation of results in the context of device registration requirements aligned with the business need and goals. 
• In collaboration with respective CSL stakeholders, support the global program planning and regulatory device strategy discussions. This includes facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders. 
• Perform device regulatory assessments during due diligence for acquisitions, licensing, and partnerships. 
• Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its product portfolio. 
• Provide regulatory consultation to internal CSL functions, including Plasma Operations, Global Operations functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence. 
• Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements. 
• Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Plasma Operations, Global Operations, and R&D, and stakeholder network. 
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