Global Regulatory Affairs Specialist: Medical Devices

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

Benefits offered by this job

Health insurance

Dental and vision coverage

401(k) with company match

Paid time off and holidays

Job summary

OrganOx Limited in Madison, NJ, is seeking a Regulatory Affairs Specialist to support global regulatory submissions and product lifecycle activities with a focus on regulatory information management.

The role reports to the Director of Regulatory Affairs and collaborates with regulatory colleagues and cross-functional partners. This is a hybrid position in Madison, with approx. 2 days in the office and up to 5% travel.

Qualifications

• Bachelor's degree required in a technical field and 3+ years in regulatory affairs.
• Experience with medical devices regulatory submissions preferred.
• Knowledge of international markets (EU/Canada/AUS) a plus.

Responsibilities

• Prepare and submit regulatory filings for US, EU, Canada, and other markets.
• Coordinate regulatory deliverables across product areas.
• Maintain accurate regulatory records and lifecycle data.
• Support Notified Body interactions as needed.
• Contribute to Rimsys configuration and improvements.
• Align regulatory records with change controls and configurations.
• Ensure timely renewals, registrations, and reports.
• Collaborate with cross-functional teams including Manufacturing and QA.

Skills

Regulatory affairs

FDA regulatory processes

Regulatory documentation

Cross-functional collaboration

Attention to detail

Organizational skills

Verbal communication

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Rimsys

Job description

OrganOx Limited in Madison, NJ, is seeking a Regulatory Affairs Specialist to support global regulatory submissions and product lifecycle activities with a focus on regulatory information management.

The role reports to the Director of Regulatory Affairs and collaborates with regulatory colleagues and cross-functional partners. This is a hybrid position in Madison, with approx. 2 days in the office and up to 5% travel.