Global Medical Device Regulatory Strategist - Contract

Next Generation Technology, Inc; Northbrook (IL); Hybrid; USD 75,000 - 95,000; Part time

Job summary

Next Generation Technology, Inc is seeking a detail-oriented Regulatory Affairs Consultant to join their team. This position involves developing regulatory strategies for U.S. and global markets, preparing essential documentation for FDA submissions, and ensuring compliance with international medical device regulations.

The ideal candidate will have a Bachelor’s degree and over 5 years of experience in regulatory affairs within the medical device industry. Both on-site and remote work options are available.

Qualifications

• 5+ years of hands-on regulatory affairs experience in the medical device industry.
• Experience with both Class I and Class II medical devices.
• Meticulous attention to detail and excellent organization skills.

Responsibilities

• Develop and execute regulatory strategies for U.S. and global market access.
• Prepare and maintain documentation for 510(k) submissions and product registrations.
• Conduct regulatory assessments for new product development and labeling.

Skills

Regulatory strategies development

FDA knowledge

ISO 13485 compliance

Communication skills

Project management

Education

Bachelor’s degree in Life Sciences, Engineering, or Regulatory Affairs

Job description

Next Generation Technology, Inc is seeking a detail-oriented Regulatory Affairs Consultant to join their team. This position involves developing regulatory strategies for U.S. and global markets, preparing essential documentation for FDA submissions, and ensuring compliance with international medical device regulations.

The ideal candidate will have a Bachelor’s degree and over 5 years of experience in regulatory affairs within the medical device industry. Both on-site and remote work options are available.