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Job Description
Title:
Regulatory Affairs & Quality Systems Specialist Location:
Pewaukee, WI (On-Site)
Job Summary:
The incumbent is responsible for advancing 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.
Key Responsibilities & Duties:
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. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
Education & Qualifications:
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.
Preferred Qualifications:
Proven success working in cross-functional, matrixed organizations. 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.
Physical Demands & 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.
Equal Opportunity Employer:
We are proud to foster an inclusive and diverse workplace culture. We are an equal opportunity employer and are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetics, or any other characteristic protected by applicable federal, state, or local law. We value diversity and believe that a diverse and inclusive workforce is essential to drive innovation, foster creativity, and achieve success. We welcome and encourage applications from individuals of all backgrounds and are dedicated to ensuring a fair and equitable recruitment and employment process for everyone.
Job Type:
Full-time Pay:
$70,000.00 - $99,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): Will you now or in the future require work visa sponsorship?
Education:
Bachelor's (Required)
Experience:
Regulatory Affairs and/or
Quality Systems :
5 years (Required) medical device or SaMD industry: 5 years (Required) Ability to
