Regulatory Affairs Manager Job Morrisville area,North Carolina USA,Healthcare

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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

Develop and implement regulatory strategies for diagnostic devices, ensuring well-organized and high-quality submissions.

Partner with internal teams to solve technical and strategic challenges affecting the diagnostic device portfolio.

Communicate regulatory scenarios, risks, mitigations, and recommended paths aligned with business goals.

Monitor external regulatory trends and lead regulatory measures to maintain competitive advantage.

Act as RA SME, contribute to department priorities, and support global submission activities and compliance tasks.

External Influencing and Capability Building

Engage with Health Authorities on policy issues and build trusted relationships.

Represent the company in external venues, create regulatory positions, and disseminate them.

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.

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