LED Light Therapy Device Clinical Report Review
Budget: $25 – $50 AUD
Project Overview
We are seeking a qualified clinical or regulatory professional to review, provide feedback on,
and formally sign off on a Clinical Evaluation Report (CER) prepared for a Class I medical
device (non-invasive LED light therapy device) intended for inclusion on the Australian
Register of Therapeutic Goods (ARTG).
The device — a Wireless LED Light Therapy Device — is a non-invasive, portable
LED panel that emits clinically studied wavelengths (Red, Blue, Yellow, Infrared, etc.) for skin rejuvenation and cosmetic skin support. The CER is part of our response to an audit request
under Section 41JA of the Therapeutic Goods Act 1989.
What We Need
We are looking for a professional to:
- Review our draft Clinical Evaluation Report (CER) for accuracy, completeness, and TGA compliance.
- Ensure the report aligns with TGA Clinical Evidence Guidelines and Essential
Principle 14.
- Provide a signed declaration or endorsement as a qualified expert, as required by the
TGA
- Optionally, provide edits or additions to strengthen literature analysis or summary of
clinical data (if needed)
Who You Are
We welcome applications from:
Suitable Profiles:
- Medical Doctor (MD / MBBS / DO) with experience in dermatology,
photobiomodulation, or aesthetic medicine.
- Clinical Researcher / PhD in biomedical sciences with experience in medical device
clinical evaluation
- Regulatory Affairs Consultant experienced with CER writing, EU MDR or TGA
submissions
- Biomedical Engineer / Scientist with LED or low-risk medical device experience and
knowledge of GHTF/SG5/N2R8:2007 or MEDDEV 2.7.1 rev. 4 methodologies
* Australian registration (AHPRA) is not required but considered a bonus. *
Skills & Experience
- Experience with TGA, CE Marking, or FDA Class I or II device submissions
- In-depth knowledge of Essential Principles, Schedule 3 of the TGA Medical Device
Regulations, and GMDN classifications
Experience working with LED or cosmetic dermatology devices preferred
- Ability to provide a statement of expertise and formally endorse the report
Deliverables
- Reviewed & annotated CER (Word or PDF)
- Signed endorsement page / declaration of clinical expert
- Credentials summary or short CV (for TGA submission)
(Optional) High-level feedback on CER improvements
Timeline
- Deadline for delivery: Wednesday, 11 September 2025
- Estimated work time: 3–5 hours (negotiable depending on input required)
Budget
- Flexible based on experience
- Open to fixed price or hourly rate
- Please include your quote, resume or profile, and examples of relevant past work
To Apply
Please submit:
- A brief cover note highlighting your suitability
CV or LinkedIn profile
- Examples of relevant experience
- Confirmation of availability to deliver by 11 September 2025
- Your quote
We are seeking a qualified clinical or regulatory professional to review, provide feedback on,
and formally sign off on a Clinical Evaluation Report (CER) prepared for a Class I medical
device (non-invasive LED light therapy device) intended for inclusion on the Australian
Register of Therapeutic Goods (ARTG).
The device — a Wireless LED Light Therapy Device — is a non-invasive, portable
LED panel that emits clinically studied wavelengths (Red, Blue, Yellow, Infrared, etc.) for skin rejuvenation and cosmetic skin support. The CER is part of our response to an audit request
under Section 41JA of the Therapeutic Goods Act 1989.
What We Need
We are looking for a professional to:
- Review our draft Clinical Evaluation Report (CER) for accuracy, completeness, and TGA compliance.
- Ensure the report aligns with TGA Clinical Evidence Guidelines and Essential
Principle 14.
- Provide a signed declaration or endorsement as a qualified expert, as required by the
TGA
- Optionally, provide edits or additions to strengthen literature analysis or summary of
clinical data (if needed)
Who You Are
We welcome applications from:
Suitable Profiles:
- Medical Doctor (MD / MBBS / DO) with experience in dermatology,
photobiomodulation, or aesthetic medicine.
- Clinical Researcher / PhD in biomedical sciences with experience in medical device
clinical evaluation
- Regulatory Affairs Consultant experienced with CER writing, EU MDR or TGA
submissions
- Biomedical Engineer / Scientist with LED or low-risk medical device experience and
knowledge of GHTF/SG5/N2R8:2007 or MEDDEV 2.7.1 rev. 4 methodologies
* Australian registration (AHPRA) is not required but considered a bonus. *
Skills & Experience
- Experience with TGA, CE Marking, or FDA Class I or II device submissions
- In-depth knowledge of Essential Principles, Schedule 3 of the TGA Medical Device
Regulations, and GMDN classifications
Experience working with LED or cosmetic dermatology devices preferred
- Ability to provide a statement of expertise and formally endorse the report
Deliverables
- Reviewed & annotated CER (Word or PDF)
- Signed endorsement page / declaration of clinical expert
- Credentials summary or short CV (for TGA submission)
(Optional) High-level feedback on CER improvements
Timeline
- Deadline for delivery: Wednesday, 11 September 2025
- Estimated work time: 3–5 hours (negotiable depending on input required)
Budget
- Flexible based on experience
- Open to fixed price or hourly rate
- Please include your quote, resume or profile, and examples of relevant past work
To Apply
Please submit:
- A brief cover note highlighting your suitability
CV or LinkedIn profile
- Examples of relevant experience
- Confirmation of availability to deliver by 11 September 2025
- Your quote