Regulatory Affairs Consultant (Peru) – DIGEMID Dossier Submission for Medical Implants
Budget: ₹1,500 – ₹12,500 INR
Description:
We are Giaplus Medical Pvt Ltd, an orthopedic implant manufacturer based in India. We are looking for an experienced Regulatory Affairs Specialist based in Peru who can support us in registering our orthopedic implants and surgical instruments with DIGEMID (Peruvian regulatory authority for medical devices).
We are seeking a freelance consultant or regulatory expert who can:
Scope of Work:
Guide us through the regulatory process for registering Class I/II orthopedic implants in Peru
Review and prepare the necessary documentation
Translate and format documents as per DIGEMID requirements (Spanish)
Submit the product dossier through VUCE (Peru’s Single Window Foreign Trade system)
Act as our local regulatory representative (if required)
We already have the following certifications:
ISO 13485:2016
ISO 9001:2015
CE Certificate (non-4-digit, from European-accredited body)
Indian FDA (MD-9 License)
Timeline:
We aim to complete the registration process within 4–6 weeks
Preferred Qualifications:
Experience submitting dossiers to DIGEMID for medical devices or implants
Fluent in Spanish and English
Familiarity with VUCE platform
Based in Peru or able to represent our company locally
Please share your experience, portfolio (if applicable), expected timeline, and total fee.
Looking forward to working with a reliable partner to help us enter the Peruvian market.
We are Giaplus Medical Pvt Ltd, an orthopedic implant manufacturer based in India. We are looking for an experienced Regulatory Affairs Specialist based in Peru who can support us in registering our orthopedic implants and surgical instruments with DIGEMID (Peruvian regulatory authority for medical devices).
We are seeking a freelance consultant or regulatory expert who can:
Scope of Work:
Guide us through the regulatory process for registering Class I/II orthopedic implants in Peru
Review and prepare the necessary documentation
Translate and format documents as per DIGEMID requirements (Spanish)
Submit the product dossier through VUCE (Peru’s Single Window Foreign Trade system)
Act as our local regulatory representative (if required)
We already have the following certifications:
ISO 13485:2016
ISO 9001:2015
CE Certificate (non-4-digit, from European-accredited body)
Indian FDA (MD-9 License)
Timeline:
We aim to complete the registration process within 4–6 weeks
Preferred Qualifications:
Experience submitting dossiers to DIGEMID for medical devices or implants
Fluent in Spanish and English
Familiarity with VUCE platform
Based in Peru or able to represent our company locally
Please share your experience, portfolio (if applicable), expected timeline, and total fee.
Looking forward to working with a reliable partner to help us enter the Peruvian market.