Global Regulatory Affairs Specialist - MedTech (Hybrid)

OrganOx Limited; Alabama; Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health, dental, vision coverage

401(k) with company match

Paid time off

Holidays and leave benefits

Onsite wellness facility

Job summary

OrganOx Limited in Madison, NJ, is seeking a Regulatory Affairs Specialist to support global regulatory submissions, registrations, and product lifecycle activities for OrganOx devices, with emphasis on regulatory information management and cross‑functional coordination.

You will work with software, hardware, and disposable products teams, maintain regulatory records, and support audits and Notified Body interactions, with up to 5% travel and a hybrid work arrangement.

Qualifications

• Knowledge of medical device regulatory requirements and FDA processes.
• Ability to prepare clear regulatory documentation and submissions.
• Experience with regulatory requirements in EU, Canada, Australia.
• Experience with regulatory information management systems (Rimsys preferred).
• Experience collaborating across Manufacturing, Quality, R&D, Clinical, Marketing, and other functions.
• Strong organizational skills and attention to detail.
• Excellent verbal communication and technical writing skills.

Responsibilities

• Prepare, compile, review, and submit regulatory filings for OrganOx products in multiple markets.
• Coordinate regulatory deliverables across product areas and regulatory systems.
• Support regulatory authority interactions and Notified Body activities.
• Maintain accurate regulatory records, registrations, licenses, and commitments.
• Collaborate with cross-functional teams to communicate regulatory requirements.
• Assist with process improvements and regulatory system enhancements (Rimsys).

Skills

Regulatory requirements

FDA processes

Regulatory docs

Rimsys experience

Cross-functional collaboration

Organization

Technical writing

Education

Bachelor’s degree in engineering/life sciences

3+ years medical device regulatory experience

Tools

Rimsys

Job description

OrganOx Limited in Madison, NJ, is seeking a Regulatory Affairs Specialist to support global regulatory submissions, registrations, and product lifecycle activities for OrganOx devices, with emphasis on regulatory information management and cross‑functional coordination.

You will work with software, hardware, and disposable products teams, maintain regulatory records, and support audits and Notified Body interactions, with up to 5% travel and a hybrid work arrangement.