Senior Regulatory Affairs Lead - SaMD/MedTech (Remote)

OrganOx Limited; Madison (NJ); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health, dental, vision, disability

401(k) with company match

Paid time off and wellness facilities

Employee discounts

Job summary

OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to ensure compliance with ISO, GMP, and medical device standards.

The position offers flexible remote or hybrid on-site work in Madison, NJ with travel up to 5% domestically or internationally, and reports to the Director of

Qualifications

• Experience with FDA regulatory pathways for medical devices (510(k)/PMA).
• Experience with SaMD/SiMD, cybersecurity, and electromechanical devices.
• Familiarity with Class II/III regulatory requirements and quality systems.
• Ability to craft regulatory strategies and submissions and communicate with agencies.

Responsibilities

• Prepare regulatory submissions (FDA/Health Canada) and maintain submission calendars.
• Support pre- and post-market regulatory activities and lifecycle changes.
• Collaborate with Manufacturing, Quality, R&D, Clinical and Marketing teams.
• Interface with FDA and Health Canada; respond to information requests.
• Monitor changes to US/Canada regulations and international standards.

Skills

FDA processes

SaMD/SiMD/Cybersecurity

Class II/III devices

Regulatory submissions

GMP knowledge

Cross-functional

MS Office

Communication

Independent work

Education

Bachelor’s degree in engineering or life sciences

RAC (optional)

Job description

OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to ensure compliance with ISO, GMP, and medical device standards.

The position offers flexible remote or hybrid on-site work in Madison, NJ with travel up to 5% domestically or internationally, and reports to the Director of