Quality & Regulatory Affairs Manager

Location: Euclid, OH (Cleveland area) - Hybrid, with on-site presence 3-4 days per week. On-site presence is important for audits, training, and process observation, but much of this role involves focused documentation work that can be done remotely.

Company: General Sleep Corporation

About Us

We are a medical device company based in Euclid, OH. We design, manufacture, and sell FDA-cleared Class II home sleep testing devices, serving hospitals, sleep labs, and patients directly through our ship-to-patient sleep testing service. We're looking for a Quality & Regulatory Affairs Manager to lead our quality system modernization efforts and own our regulatory compliance program.

About the Role

This is a hands-on leadership role. You will be the primary owner of our FDA quality management system, responsible for aligning it with the current QMSR / ISO 13485 requirements. You'll select and implement an eQMS platform, build out documentation and procedures, and work closely with our operations and engineering teams to ensure the system is followed day-to-day.

We're looking for someone who can build and improve, not just audit what already exists. You'll have real authority to shape how our quality system works and direct support from company leadership.

Primary Responsibilities

Overhaul and maintain the company's Quality Management System to comply with FDA QMSR and ISO 13485 requirements. Lead the selection and implementation of an eQMS platform with your input and experience driving the final decision. Develop, document, and maintain quality policies, procedures, SOPs, and work instructions. Manage CAPA, complaint handling, nonconformance, and document control processes. Prepare for and lead FDA inspections and audits. Work with the operations team to ensure manufacturing, repair, supplier, and logistics processes are documented and followed per QMS requirements. Coordinate management reviews, internal audits, and training programs. Manage supplier quality, including supplier qualification and ongoing monitoring.

Secondary Responsibilities

Many aspects of HIPAA and SOC 2 compliance overlap directly with QMS work, such as training tracking, vendor qualification, periodic reviews, document control, and audit preparation. For these areas, you'll be a natural fit and we'd expect you to take an active role in managing them, since the skills and processes are essentially the same ones you'll already be applying to our quality system. For the more technical and IT-specific aspects of HIPAA and SOC 2 (security configurations, access controls, vulnerability management, and the like), our engineering team handles those. No prior HIPAA or SOC 2 experience is required, however the overlapping areas will feel familiar, and we'll provide context for anything that's new.

What We're Looking For

3–8 years of experience in quality assurance or regulatory affairs in the medical device industry. Strong working knowledge of FDA 21 CFR 820 (now QMSR), ISO 13485, and the regulatory landscape for Class II medical devices. Experience building, overhauling, or significantly improving a quality management system, not just maintaining one. Familiarity with eQMS platforms is a strong plus. Experience with FDA inspections, audit responses, or warning letter remediation is highly valued. Understanding of CAPA, complaint handling, document control, and supplier quality processes. No HIPAA or SOC 2 experience needed, just a willingness to help with tasks that overlap with QMS activities. Bachelor's degree in a relevant field (engineering, life sciences, quality, regulatory) or equivalent experience. ASQ CQA, CQE, RAC, or similar certifications are a plus but not required.

What You Should Know About Working Here

This role offers significant ownership and influence over how our quality system is built. You'll work directly with leadership and have the authority to drive real change. We're investing in quality; this isn't a role where you'll fight for resources or attention.

You'll work closely with our Operations Manager and engineering team. If you thrive on building systems and seeing the impact of your work directly, this is a great fit.

Compensation & Benefits

Salary range: $95,000 - $125,000, depending on experience. Health insurance with employer contribution. Dental, vision, life, and legal benefits. PTO and paid holidays. Professional development support (certifications, conferences, memberships).