Regulatory Documentation & Compliance Specialist (FCC, CE, FDA, RoHS, Cybersecurity)

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) :

Required Qualifications

Deliverables

Skills Required

Iso 13485, Iso 27001, iec 60601 , ce marking