Regulatory Affairs Consultant

Posted yesterday

next generation technologyNorthbrook (IL)

Regulatory Affairs Specialists Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Senior

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About the role

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

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