Regulatory Affairs Manager

Join to apply for the Regulatory Affairs Manager role at Align Technology 5 days ago Be among the first 25 applicants Description 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). This role will: Provide strategic device regulatory decisions on strategies and risk management of the diagnostic device portfolio throughout the product lifecycle. Solve unique and strategic challenges impacting the diagnostic device portfolio in a dynamic regulatory environment. Establish trusted relationships with industry partners and interface with health authorities to influence industry best practices and the regulatory landscape. Department and Location Legal department, US-Arizona-Tempe-Corp HQ Requirements Bachelor’s degree in engineering, regulatory affairs, quality, or related field. 6-10 years of experience in regulatory affairs, quality, device development, or related fields in the medical device industry. Higher education can substitute for experience. Extensive experience with diagnostic SaMD products, US FDA regulations, and global standards. Ex-health authority regulatory experience is highly desirable. Strong relationships with regulators and external groups to influence policies. Solid understanding of Design Control, FDA QSR, ISO 13485, and MDSAP. Excellent time management, organization, and multitasking skills. Proficiency in Microsoft Office. Ability to travel up to 10% domestically and internationally. Additional Skills Strategic thinking, influence, and communication skills to work with senior leaders and external stakeholders. Self-directed, collaborative, and adaptable in a fast-paced environment. Other Information Includes privacy policy, diversity statement, and equal opportunity employer statement. #J-18808-Ljbffr Align Technology