Advanced Specialist, Regulatory Product Strategy & Delivery (Remote)

The primary role of the Regulatory Affairs function is to provide support and guidance with respect to the regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to the business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence and excellence in execution. Ensuring that systems and processes are established to enable ResMed to comply with multiple regulatory frameworks, in order to support the design, development and manufacture of products which meet our customer’s quality requirements. Working closely with all internal stakeholders and external regulators to achieve business goals. This role supports software-driven and digital health solutions, including Software as a Medical Device (SaMD) and algorithm-driven functionality (including AI/ML-enabled features), and requires experience evaluating regulated and non-regulated digital health technologies based on intended use and applicable regulatory frameworks. Acting as a regulatory partner within cross-functional teams, this role translates global regulatory requirements into clear, actionable guidance and ensures regulatory strategy is integrated across intended use, claims and labeling, design controls, change management, submission planning, and post-market compliance activities. Responsibilities The primary objective of Regulatory Affairs specialization within the Regulatory Affairs Job Family is to provide strategic, tactical and operational direction and support to work within regulations and expedite the development and delivery of safe and effective devices to patients globally. Act as the Regulatory representative on cross-functional teams, providing strategic regulatory input for new product development, product modifications, and lifecycle management activities. Maintain awareness of evolving global regulatory requirements and proactively assess regulatory impact on business strategy and product development, translating requirements into actionable regulatory strategies and recommendations. Provide regulatory guidance to product development by translating regulatory requirements into clear, risk-based recommendations, including intended use, claims, product requirements, and design control activities. Author and support regulatory submissions/registrations/renewals (e.g., FDA 510(k), EU MDR Technical Documentation, and other global submissions). Perform regulatory assessments for product and software changes (e.g., software updates, algorithm modifications, labeling updates, and design changes), determining regulatory impact, required actions, and supporting appropriate regulatory pathway decisions. Evaluate regulatory status of digital health technologies, including regulated and non-regulated software functions, and determine appropriate classification and compliance pathways. Review and approve labeling, advertising, and promotional materials to ensure alignment with regulatory requirements, approved claims, and intended use. Support post-market compliance activities, including regulatory inspections, audits, recalls, and collaboration with internal stakeholders and external regulatory bodies (e.g., FDA, Notified Bodies). Support timely product launches and ongoing market access across regions through effective regulatory execution. Participate in regulatory interactions with health authorities, including Pre-Submissions, Notified Body consultations, and responses to regulatory inquiries. Network with senior internal and external personnel within the area of expertise. May lead the work of project teams and formally train and mentor junior staff. Qualifications and Experience Required Bachelor’s degree. Minimum of 3 years of related experience in a regulated industry as a regulatory affairs professional. Experience with Software as a Medical Device (SaMD) and/or digital health products. Experience authoring and contributing to FDA regulatory submissions (e.g., 510(k), De Novo, or equivalent). Experience working with EU MDR regulatory requirements. Experience authoring regulatory assessments for product and software changes. Experience authoring regulatory strategy and submissions across the product lifecycle. Ability to communicate regulatory concepts effectively to both technical and non-technical stakeholders. Preferred 5+ years of related experience in a regulated industry as a regulatory affairs professional. Experience with AI/ML-enabled medical devices or algorithm-based functionality. Experience working with cross-functional product development teams in regulated environments. Experience supporting global regulatory submissions or market access across multiple regions. Familiarity with regulatory considerations for cybersecurity, data privacy, and data governance in digital health systems. Experience working in agile or software development environments. #J-18808-Ljbffr