QA/RA Manager — FDA Submissions for Class II Devices

Planet Pharma; Pittsburgh (Allegheny County); Hybrid; USD 110,000 - 130,000; Full time

Job summary

Planet Pharma seeks a QA/RA Manager to lead the U.S. regulatory and quality assurance function for Class II medical devices. You will own FDA submissions, agency communications, and QMS improvements, coordinating with teams in Japan to align regulatory strategy.

The role requires hands-on experience preparing FDA filings, a strong compliance mindset, and leadership for one direct report. Location is Pittsburgh area with potential remote consideration for qualified candidates.

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.

Responsibilities

• Prepare, submit, and manage FDA regulatory submissions for Class II medical devices.
• Serve as primary contact with the FDA and manage requests and deficiency responses.
• 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 QA/RA support for product imports, distribution, service, and post-market activities.
• Coordinate clinical activities and regulatory support efforts as required.
• Collaborate with cross-functional teams in the U.S. and Japan for registrations and quality initiatives.
• Lead internal audits, CAPAs, investigations, and continuous improvement initiatives.
• Supervise and mentor one direct report.
• Support growth initiatives by ensuring timely regulatory approvals and ongoing compliance.

Skills

FDA submissions

Quality Assurance

Regulatory Affairs

Project management

Leadership

Education

Bachelor’s degree in Engineering/Life Sciences/Regulatory Affairs/Quality

Job description

Planet Pharma seeks a QA/RA Manager to lead the U.S. regulatory and quality assurance function for Class II medical devices. You will own FDA submissions, agency communications, and QMS improvements, coordinating with teams in Japan to align regulatory strategy.

The role requires hands-on experience preparing FDA filings, a strong compliance mindset, and leadership for one direct report. Location is Pittsburgh area with potential remote consideration for qualified candidates.