Pharma Compliance Consultant
Budget: $50 – $500 AUD
Job Title:
TGA Consultant – Class I Medical Device (Anti-Freeze Gel Pads)
Description:
Looking for someone experienced with TGA Class I medical device submissions to help me finalise documentation for listing anti-freeze gel pads used in cryolipolysis treatments.
I need guidance on:
• What documents are required for Class I (non-sterile) listing
• Help reviewing or completing the Essential Principles Checklist, Declaration of Conformity, and evidence list
• What to request from my manufacturer (e.g. ISO 13485, biocompatibility tests, MSDS)
Ideal if you’re familiar with ISO 13485, ISO 10993, and ISO 14971.
Budget: Small business — looking for a cost-effective consultant or freelancer.
Timeline: Hoping to finalise within 1–2 weeks.
Please include your experience with TGA or similar submissions and your rate.
TGA Consultant – Class I Medical Device (Anti-Freeze Gel Pads)
Description:
Looking for someone experienced with TGA Class I medical device submissions to help me finalise documentation for listing anti-freeze gel pads used in cryolipolysis treatments.
I need guidance on:
• What documents are required for Class I (non-sterile) listing
• Help reviewing or completing the Essential Principles Checklist, Declaration of Conformity, and evidence list
• What to request from my manufacturer (e.g. ISO 13485, biocompatibility tests, MSDS)
Ideal if you’re familiar with ISO 13485, ISO 10993, and ISO 14971.
Budget: Small business — looking for a cost-effective consultant or freelancer.
Timeline: Hoping to finalise within 1–2 weeks.
Please include your experience with TGA or similar submissions and your rate.