QA/RA Manager Location:

Pittsburgh Area Compensation:

$110,000 Base Salary + $10,000

Bonus Reports To:

Leadership Team in

Japan Direct Reports:

1 Position Summary The QA/RA Manager is a newly created position and will serve as the primary Quality Assurance and Regulatory Affairs leader for the U.S. business. This individual will take ownership of FDA regulatory submissions, agency correspondence, quality system activities, and day-to-day regulatory execution. The ideal candidate is a hands-on regulatory professional with demonstrated experience independently preparing and managing FDA submissions for multiple Class II medical devices throughout the product lifecycle. This role will play a critical part in bridging compliance activities between the U.S. organization and the parent company in Japan, helping streamline the FDA submission process and ensuring continued regulatory compliance within the U.S. market. Key Responsibilities Prepare, compile, submit, and manage FDA regulatory submissions for Class II medical devices. Serve as the primary point of contact with the FDA, including managing requests, deficiency responses, and ongoing communications. Maintain and enhance the U.S. Quality Management System (QMS). Ensure compliance with FDA regulations, quality standards, and applicable regulatory requirements. Manage day-to-day QA/RA operations for the U.S. organization. Provide quality and regulatory support for product imports, distribution, service, and post-market activities. Coordinate clinical activities and regulatory support efforts as required. Partner closely with cross-functional teams in both the U.S. and Japan to support product registrations, approvals, and quality initiatives. Lead internal audits, quality investigations, CAPAs, and continuous improvement initiatives as needed. Supervise and mentor one direct report. Support company growth initiatives by ensuring timely regulatory approvals and ongoing compliance. Required Qualifications Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field. 7-10+ years of Quality Assurance and Regulatory Affairs experience within the medical device industry. Hands-on experience independently preparing and submitting FDA regulatory filings. Proven track record bringing multiple medical device products through the FDA approval/clearance process. Strong working knowledge of FDA regulations governing Class II medical devices. Experience interacting directly with FDA reviewers and responding to agency feedback. Knowledge of Quality Management Systems (QMS), CAPA, audits, complaint handling, and post-market surveillance activities. Previous people management or leadership experience preferred. Excellent communication and project management skills. Ability to work independently and serve as the primary U.S.-based regulatory expert. Preferred Qualifications Experience supporting imported medical devices or global medical device organizations. Experience working with international stakeholders, particularly Asia-based teams. Knowledge of ISO 13485 and global medical device quality standards. Previous experience supporting neonatal care, hospital equipment, incubators, infant warmers, or related medical device products. Additional Considerations This position requires regular interaction with leadership teams in Japan and flexibility to accommodate meetings outside standard U.S. business hours when necessary. Candidates located near Warrendale, PA are preferred, though strong remote candidates within the Eastern or Central time zones will be considered. This is a highly visible role with significant ownership and the opportunity to establish and shape the company's

U.S. QA/RA

function.