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

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

Brainwave Sciencepanipat, haryana, in
1 day ago
Job description

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).
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    Compliance Specialist • panipat, haryana, in