FDA 510(k) Regulatory Consultant – Join Cruxi Expert Network

This is not an employment position with Cruxi. This posting is an invitation for independent / freelance FDA 510(k) Regulatory Consultants to join the Cruxi Expert Network so that potential clients can discover and contact you. As a member of the Cruxi network, your profile may be shown to medical device teams using the Cruxi platform who are seeking expert support for FDA 510(k) submissions. Cruxi’s role is limited to facilitating introductions and communication between companies and consultants. Any engagement, scope of work, fees, and contracts are agreed directly between you and the client. Typical activities you may perform for clients (outside of Cruxi, under your own contract) include: • Evaluating regulatory pathways and 510(k) strategies • Reviewing and refining AI-assisted drafts and eSTAR-ready content exported from Cruxi • Preparing, editing, and finalizing 510(k) documentation to meet FDA expectations • Advising on device classification, indications for use, substantial equivalence, and testing strategy • Supporting clients in planning, organizing, and submitting high-quality regulatory applications You remain an independent consultant at all times. Cruxi does not provide salary, employment benefits, or guarantee any minimum number of projects. Cruxi does not charge fees or shares. How to join To be considered for the Cruxi Expert Network, please complete your consultant profile here: https://cruxi.ai/pages/consultants/register.html Qualifications • Strong expertise in regulatory compliance, regulatory requirements, and regulatory affairs for medical devices • Proven experience with FDA 510(k) submissions, including strategy, preparation, and use of relevant guidance and standards • Experience in regulatory project management, including planning, organizing, and executing submission timelines • Familiarity with medical device classification, evidence planning, and eSTAR documentation is a strong advantage • Ability to work independently with clients while communicating clearly and professionally • Bachelor’s or advanced degree in a relevant field (e.g., Biomedical Engineering, Regulatory Affairs, Life Sciences, or related discipline) • Prior experience in regulatory roles within the medical device industry (in-house, consulting, or agency) is preferred • Strong attention to detail and commitment to maintaining high regulatory and documentation standards How to join To be considered for the Cruxi Expert Network, please complete your consultant profile here: https://cruxi.ai/pages/consultants/register.html Disclaimer: Cruxi is a platform and connection platform. Consultants remain independent contractors and are engaged, contracted, and paid directly by clients. Cruxi does not provide salary, benefits, or guarantee any number of projects. Apply tot his job Apply To this Job