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) :

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).