Document Controller and Compliance Officer

5 days ago


India Brainwave Science Full time

Regulatory Documentation & Compliance Specialist (FCC, CE, FDA, RoHS, Cybersecurity)   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. 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.    We are seeking an experienced Regulatory Documentation & Compliance Specialist to support the certification and compliance needs of our tech/wellness wearable device, CalmSync .    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.  Technical files / risk assessments   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.  Stay updated on evolving global regulatory requirements (RoHS, WEEE, IEC, ISO, etc.).  RoHS, WEEE (EU environmental compliance)  IEC/ISO safety and performance certifications  Cybersecurity and privacy documentation  Packaging, labeling, and user manual compliance    Proven experience preparing and submitting FCC, CE, and FDA documentation for electronic, wellness, or medical devices .  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.    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). 


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