Regulatory Documentation

Regulatory Documentation & Compliance Specialist (FCC, CE, FDA, RoHS, Cybersecurity) About Us Brainwave Science is a global neurotechnology company dedicated to transforming how brainwave data is understood and applied. With over a decade of research and innovation, the company has developed advanced cognitive assessment solutions such as iCognative™, empowering agencies across security, intelligence, and law enforcement to uncover concealed information through neuroscience. Our expertise lies in combining EEG-based analytics, AI, and cognitive neuroscience to create technologies that deliver measurable, real-world impact. Expanding this vision into wellness and lifestyle, Basil Health focuses on translating these neurotechnological insights into the consumer and wellness space. Its flagship product, CalmSync, is a next-generation neuro-wellness wearable that integrates EEG, HRV, SpO₂, and ECG data to help individuals understand and balance their mind-body connection in real time. Together, Brainwave Science and Basil Health are bridging the worlds of neuroscience and holistic wellness, redefining how technology can support mental health, mindfulness, and everyday well-being through intelligent, data-driven innovation. Description We are seeking an experienced Regulatory Documentation & Compliance Specialist to support the certification and compliance needs of our tech/wellness wearable device, CalmSync. Key Responsibilities - Determine whether the product qualifies as a wellness or medical device under FDA and CE guidelines, and advise on the correct regulatory pathway. - Prepare, review, and manage documentation for FCC, CE, FDA (wellness/general use/510(k)), RoHS, and cybersecurity compliance. - Ensure all certifications meet relevant regional and international standards (US, EU, India, and other target markets). - Draft, organize, and maintain: - Declarations of Conformity (DoC) - Technical files / risk assessments - FDA registration paperwork (if applicable) - RoHS / WEEE environmental documentation - Cybersecurity and privacy compliance checklists - Packaging, labeling, and user manual compliance - Liaise with manufacturers, testing labs, and internal teams to gather and validate all required documents. - Advise on additional certifications and standards that may be relevant (e.g., ISO 13485, IEC 60601, ISO 27001, etc.). - Stay updated on evolving global regulatory requirements (RoHS, WEEE, IEC, ISO, etc.). - Ensure all documentation is well-organized, version-controlled, and audit-ready. Key Certifications & Documents Include (but are not limited to): - FCC certification and labeling requirements - CE marking (RED, EMC, LVD, etc.) - FDA 510(k) or wellness device documentation - RoHS, WEEE (EU environmental compliance) - IEC/ISO safety and performance certifications - Cybersecurity and privacy documentation - Technical file / design dossier / device master file - Packaging, labeling, and user manual compliance Required Qualifications - Proven experience preparing and submitting FCC, CE, and FDA documentation for electronic, wellness, or medical devices. - Strong knowledge of global product regulations (USA, EU, and Asia-Pacific). - Ability to advise on classification strategy (wellness vs. medical device) and regulatory pathways. - Familiarity with RoHS, WEEE, and cybersecurity requirements. - Excellent technical writing, documentation management, and project coordination skills. - Prior experience working with international certification bodies and supporting product launches is preferred. - Fluency in written technical English and strong cross-functional communication skills. Deliverables - Regulatory classification and compliance strategy for CalmSync (FCC, CE, FDA). - Updated and complete documentation set under the CalmSync brand (including DoC, technical file, risk summary). - Regional certification matrix (US, EU, India, Middle East, etc.). - Guidance or assistance with FDA registration (if applicable).