Regulatory Affairs Manager

Align Technology; Morrisville (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager to lead the development and execution of regulatory strategies for medical devices. This pivotal role involves navigating complex regulatory landscapes, influencing industry best practices, and ensuring compliance with health authority regulations. The ideal candidate will possess a strong background in regulatory affairs, particularly with diagnostic devices, and demonstrate exceptional leadership and communication skills. Join a forward-thinking company that values diversity and fosters an inclusive work environment, where your expertise will contribute significantly to the success of innovative medical solutions.

Qualifications

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

Responsibilities

• Develop and implement regulatory strategies for diagnostic devices.
• Engage with Health Authorities on policy issues and build trusted relationships.

Skills

Regulatory Affairs

Leadership

Critical Thinking

Collaboration

Influencing Skills

Time Management

Strategic Thinking

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:

• Provide strategic device regulatory decisions on strategies and risk management of the diagnostic device portfolio throughout the entire 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:

Legal

Location:

US-North Carolina-Raleigh

Role Requirements

This position requires in-depth US device regulatory knowledge, experience throughout the product lifecycle, strong leadership, critical thinking, collaboration, and influencing skills. Ex-health authority regulatory experience is highly desirable.

Responsibilities

1. Develop and implement regulatory strategies for diagnostic devices, ensuring well-organized and high-quality submissions.
2. Partner with internal teams to solve technical and strategic challenges affecting the diagnostic device portfolio.
3. Communicate regulatory scenarios, risks, mitigations, and recommended paths aligned with business goals.
4. Monitor external regulatory trends and lead regulatory measures to maintain competitive advantage.
5. Act as RA SME, contribute to department priorities, and support global submission activities and compliance tasks.

External Influencing and Capability Building

1. Engage with Health Authorities on policy issues and build trusted relationships.
2. Represent the company in external venues, create regulatory positions, and disseminate them.
3. Mentor internal teams on regulatory strategy and risk management.

Qualifications

• Bachelor’s degree in engineering, regulatory affairs, quality, or related field.
• 6-10 years of experience in regulatory affairs, device development, or related fields; higher education can substitute experience.
• Extensive experience with diagnostic SaMD products and US FDA regulations/global standards; ex-health authority experience is a plus.
• Proven ability to influence regulators and external groups effectively.
• Strong understanding of Design Control, FDA QSR, and ISO 13485 MDSAP.
• Excellent prioritization, time management, analysis, and organizational skills.
• Proficiency in Microsoft Office.
• Ability to travel domestically and internationally, up to 10%.

Additional Skills

• Strategic and critical thinking with a results-oriented approach.
• Effective communicator capable of influencing others, including senior leaders.
• Adaptability to dynamic, matrix environments.
• Independent yet collaborative team player.

Additional Information

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At Align, we value diversity and are committed to an inclusive workforce.

Align Technology is an equal opportunity employer, welcoming applicants regardless of race, gender, religion, or other protected categories.