Regulatory Affairs Specialist, Medical Devices (Hybrid)

OrganOx; Madison (NJ); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health, dental, vision, disability

401(k) with company matching

Paid time off and holidays

Onsite wellness facility

Job summary

OrganOx, a leading organ-technology company, seeks a Regulatory Affairs Specialist in Madison, NJ for hybrid work. You will support global regulatory submissions, registrations, and lifecycle management with a focus on regulatory information management and cross-functional coordination across software, hardware, and labeling teams.

The role reports to the Director of Regulatory Affairs and may travel up to 5% to OrganOx and supplier sites.

Qualifications

• Experience with FDA regulatory submissions and filings.
• Knowledge of international regulatory requirements (EU, Canada, Australia).
• Ability to prepare clear regulatory documentation and submissions.

Responsibilities

• Support the preparation and submission of regulatory filings across markets.
• Coordinate regulatory activities across software, hardware, disposables, and labeling.
• Maintain accurate regulatory records and product registrations.
• Assist with regulatory authority interactions andNotified Body communications.
• Support regulatory information management system implementations and changes.
• Ensure alignment of regulatory records with change controls and product configurations.
• Collaborate with cross-functional stakeholders to meet regulatory requirements.
• Adhere to OrganOx Code of Conduct and policies.

Skills

FDA regulatory processes

Regulatory documentation

Cross-functional collaboration

Attention to detail

Verbal communication

Technical writing

Regulatory information management

Rimsys

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Rimsys

Job description

OrganOx, a leading organ-technology company, seeks a Regulatory Affairs Specialist in Madison, NJ for hybrid work. You will support global regulatory submissions, registrations, and lifecycle management with a focus on regulatory information management and cross-functional coordination across software, hardware, and labeling teams.

The role reports to the Director of Regulatory Affairs and may travel up to 5% to OrganOx and supplier sites.