The Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global standards. The devices in scope include standalone physical devices, software in medical device (SiMD) and software as a medical device (SaMD). In particular, this role will (a) provide strategic device regulatory decisions on strategies and risk management of the diagnostic device portfolio throughout the entire product lifecycle, (b) solve unique and strategic challenges with broad impact on the growing diagnostic device portfolio in a dynamic regulatory environment, and (c) establish trusted relationships with industry partners and interface with health authorities with the goal to influence industry best practices and regulatory landscape intentionally. This position requires in depth and breadth of US device regulatory knowledge and experience throughout the product life cycle, strong leadership, critical thinking, collaboration and influencing skills. Ex-health authority regulatory experience is highly desirable. Regulatory Strategy and Execution * Develop and implement regulatory strategies for diagnostic devices including standalone physical devices, software in medical device (SiMD) and software as a medical device (SaMD). Ensure regulatory submissions are well-organized, scientifically accurate, of high quality, and presented in a way that facilitates agency review and fulfills strategic goals. * Partners with relevant internal business partners and lead the effort to solve technical and strategic challenges with broad impact on the diagnostic device portfolio, including product technical development, study design, verification and validation strategies, etc. * Articulate potential regulatory scenarios and the associated risks/mitigations and recommend a path forward in alignment with business objectives. * Monitor external regulatory trends to anticipate potential business/regulatory risks at the portfolio level. Communicate potential risks and lead the implementation of regulatory measures to ensure competitive advantages and success of the product portfolio. * Act as RA SME in assigned area and contribute to RA department priorities with a focus on enhancing regulatory intelligence and driving regulatory strategy execution. * As assignment by management, may support global submission activities (new product development, sustaining products, new/updated features, etc.), regulatory compliance or operation activities (recall, non-conformance, audit, process improvement, country approval, distribution control, annual update, post-market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.) External Influencing, Capability and Culture Building * Influence and interact directly with Health Authorities on policy issues that support our portfolio. Build trusted relationships with industry partners and Health Authorities. * Represent Align Technology in relevant external influencing venues. Lead the effort to create external regulatory positions and disseminating the positions via external influencing venues (e.g. working/trade groups, publications, presentations, etc.). * Actively engaged in coaching and mentoring internal cross-functional team on regulatory strategy and risk management. Build and cultivate a strong partnership with internal business partners.