Regulatory Affairs & Quality Systems Specialist (SaMD)

Neosoft LLC • City of Pewaukee, WI

1d

About The Position

Position Summary: The incumbent is responsible for advancing NeoSoft’s regulatory and quality strategy for its cardiac imaging Software as a Medical Device (SaMD) portfolio. This role provides hands-on support for U.S. FDA and international regulatory compliance, ensures the effectiveness of the Quality Management System (QMS), and supports product development and lifecycle activities in a highly regulated environment.

Requirements

• Bachelor’s degree in a relevant technical, engineering, or life sciences discipline.
• Minimum of 5 years of experience in Regulatory Affairs and/or Quality Systems within the medical device or SaMD industry.
• Demonstrated hands-on experience leading FDA 510(k) submissions.
• Established working knowledge of FDA QMSR, ISO 13485, IEC 62304, ISO 14971, and related regulatory requirements.
• Strong regulatory judgment and ability to apply regulations pragmatically in a fast-paced development environment.
• Excellent written and verbal communication skills, including the ability to interface with regulators and internal stakeholders.
• Ability to work independently, prioritize effectively, and make sound, proactive decisions.
• Proven success working in cross-functional, matrixed organizations.

Nice To Haves

• Experience with cardiac imaging, radiology software, or diagnostic imaging systems.
• Direct experience with SaMD and Medical Device Software (MDSW).
• Hands-on experience preparing EU MDR technical documentation.
• Familiarity with DICOM standards and cardiac clinical workflows.

Responsibilities

• Supports U.S. FDA submissions, primarily 510(k), including preparation and maintenance of Design History Files (DHF), Device Master Records (DMR), and associated technical documentation.
• Provides input into regulatory strategies for varying markets (i.e. U.S., EU (MDR), and UKCA ).
• Provides regulatory guidance on intended use statements, performance claims, labeling, and promotional considerations.
• Monitors and assesses changes to applicable regulations, guidance documents, and standards; proactively communicates impact and recommendations.
• Supports the Quality Management System (QMS), encompassing CAPA, complaint handling, post-market surveillance, vigilance reporting, internal audits, and ongoing quality improvements.
• Ensures compliance with applicable standards, including IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability engineering).
• Supports software releases by performing regulatory impact assessments, change evaluations, and documentation updates.
• Provides regulatory and quality input as it relates to cybersecurity risk management, field actions, and corrective actions, as applicable.
• Executes core duties and responsibilities of the role in accordance with the established skills competencies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees