Regulatory Affairs & Quality Systems Specialist (SaMD) at Neosoft LLC

City of Pewaukee, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Aug, 26

Salary

98000.0

Posted On

02 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA 510(k) Submissions, Quality Management Systems, SaMD Compliance, Design History Files, ISO 13485, IEC 62304, ISO 14971, IEC 62366, CAPA, Post-Market Surveillance, Regulatory Strategy, Cybersecurity Risk Management, EU MDR, UKCA, Technical Documentation, Risk Management

Industry

Software Development

Description

Description 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. Job Duties and 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. Requirements Essential Skills and Experience: 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. Preferred Qualifications: 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. Reporting to this position: No direct reports Physical demands and work environment: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical demands: While performing duties of job, employee is frequently required to type, sit, stand; walk; use hands, talk and hear; occasionally reach with hands and arms. Employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Work Environment: The noise level in the work environment is minimal.

Responsibilities

The role is responsible for advancing the regulatory and quality strategy for cardiac imaging Software as a Medical Device (SaMD) portfolios. Key duties include managing FDA 510(k) submissions, maintaining the Quality Management System, and ensuring compliance with international regulatory standards.