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, SpOâ‚‚, 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).
