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

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

About Us

Brainwave Science

Basil Health

Brainwave Science and Basil Health

Description

Regulatory Documentation & Compliance Specialist

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). 

To Apply

resume

  📧 support@basilhealth.com / areddy@brainwavescience.com 

Learn more: https://basilhealth.ai/