Regulatory Affairs Consultant

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

We are currently seeking a detail-oriented, experienced Regulatory Affairs Consultant to join our team on a contract basis. The opportunity is preferred to be on-site, but we are open to both on-site and remote options. This opportunity is ideal for a highly knowledgeable regulatory professional who thrives in a fast-paced, collaborative environment and can help support both ongoing operations and global market expansion efforts.

Role & Responsibilities

• Developing and executing regulatory strategies for U.S. and global market access (FDA, Health Canada, EU MDR, and other international markets)
• Preparing and maintaining documentation for 510(k) submissions, Technical Files, and product registrations
• Conducting regulatory assessments for new product development, labeling, and packaging
• Supporting product lifecycle changes, risk management, and post-market surveillance activities
• Ensuring ongoing compliance with U.S. FDA regulations, ISO 13485, and international medical device requirements
• Reviewing labeling, IFUs, and marketing materials for regulatory compliance
• Interfacing with internal teams and external partners to ensure clear, compliant communication and documentation
• Advising on regulatory implications of product changes and maintaining registration timelines

Skills & Experience

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field (Master’s or RAC certification a plus)
• 5+ years of hands-on regulatory affairs experience in the medical device industry
• Demonstrated experience with both Class I and Class II medical devices
• Strong working knowledge of FDA submissions (including 510(k)) and EU MDR Technical Files
• Experience supporting international registrations and country-specific regulatory requirements
• Meticulous attention to detail, excellent organization and communication skills
• Ability to manage multiple projects independently while collaborating cross-functionally