Regulatory Affairs Manager

Align Technology; Tempe (AZ); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager to lead and execute regulatory strategies for innovative medical devices. This pivotal role involves navigating complex regulatory landscapes, influencing best practices, and building relationships with health authorities. The ideal candidate will possess extensive experience in regulatory affairs, particularly with diagnostic software products, and demonstrate strong strategic thinking and communication skills. Join a dynamic team where your expertise will shape the future of medical technology and ensure compliance with global standards.

Qualifications

• 6-10 years of experience in regulatory affairs in the medical device industry.
• Extensive experience with diagnostic SaMD products and US FDA regulations.

Responsibilities

• Develop and execute regulatory strategies for medical devices.
• Provide strategic regulatory decisions throughout the product lifecycle.

Skills

Regulatory Affairs

Quality Management

Device Development

Strategic Thinking

Communication Skills

Education

Bachelor’s Degree in Engineering

Bachelor’s Degree in Regulatory Affairs

Bachelor’s Degree in Quality

Tools

Microsoft Office

Job description

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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:

1. Provide strategic device regulatory decisions on strategies and risk management of the diagnostic device portfolio throughout the product lifecycle.
2. Solve unique and strategic challenges impacting the diagnostic device portfolio in a dynamic regulatory environment.
3. 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

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