Job Description

IFU Creator/Technical Writer

ISO13485/MDR Medical Devices

OVERVIEW:

Our client partner is on an exciting journey. As a growing leader in the Cardiology medical device industry, they are on a mission towards CE Mark and FDA approval in Q4 2025.

This has come off the back of some fantastic clinical study results too.

Do you want to be part of something special?

They are seeking an experienced Regulatory Technical Writer, with the key focus being the go to person for the ‘instruction manual creation’ for users.

If this is you? Please read on……….

KEY ACCOUNTABILITIES:

• Creation and management of the IFU, patient brochure and Implant card.
• Dealing with several variations of the documentation (especially electronic/software updates) for the Medical Device.
• Essentially you will be responsible for the written instructions for the use of this Medical Device.

SKILLS/EXPERIENCE REQUIRED:

• Must have experience in the independent creation and management of instructions for use for medical devices.
• Should have experience with the development of supporting software solutions such as glossaries or editing systems.
• Should very much like to have experience with implantable high-risk products (desirable is Class III).
• If you have worked on a noval medical device, this is strong desirable too.
• Ability to understand complex technologies.
• Effective communication skills for collaboration with multidisciplinary teams and regulatory authorities.
• Ability to work independently with attention to detail.
• Excellent speaking and writing English skills.

If you do not hear back from Projectus Consulting within 7 days please assume your application has been unsuccessful on this occasion only.

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