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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.
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