Technical Writer – Medical Devices, REMOTE USA

Noramtec Consultants; Montreal; Hybrid; CAD 70,000 - 90,000; Full time

Job summary

A leading company in orthopedic devices is seeking a Technical Writer to unify their SOPs within a hybrid Clinical and Quality framework. The ideal candidate will possess a background in orthopedic medical devices and must be knowledgeable about ISO 13485 and EU MDR regulations. This position requires excellent communication skills as well as the ability to work effectively within a hybrid model.

Qualifications

• Min of 5 years of relevant work experience, preferably within Orthopedic Medical Devices.
• MUST have experience and knowledge of ISO 13485 standards and EU MDR regulations.
• Strong effective communicator, both written and spoken.

Responsibilities

• Support harmonizing SOPs across the organization.
• Utilize knowledge of Quality Systems in the role.

Skills

Communication

Quality Systems Knowledge

Clinical Knowledge

Tools

Oracle Agile

Job description

Technical Writer with a hybrid background of Clinical and Quality (70 / 30 or 60 / 40) to help our client harmonize their SOPs across the organization. Their main quality system is Oracle Agile but as long as they have quality systems experience / knowledge, they’ll be fine. This company with orthopedic devices, which is the background they prefer.

MUSThave experience and knowledge of ISO 13485 standards and EU MDR regulations.

• Candidate must have a hybrid work background within Clinical and Quality (70 / 30)
• The ideal candidate will support harmonizing SOPs across the organization
• Min of 5 years of relevant work experience, preferably within Orthopedic Medical Devices
• Working knowledge with Oracle Agile is a PLUS, but relevant Quality Systems experience will suffice
• Strong effective communicator both written and spoken