Medical Device Compliance, Systems and Engineering Change Support Administrator

at  Accora

At Accora, we create and develop assistive medical devices to help people lead as full and safe a life as possible.
We are looking for a full-time creative and hands-on medical device compliance, systems and engineering change support administrator to become an integral part of our Product Management Team. This team manages current products and focuses on product improvement, value improvement, engineering change and product systems.
This role is a unique opportunity for a creative, hands-on professional who is deeply passionate about systems and compliance within the medical equipment sector.

EXPERIENCE AND KNOWLEDGE:

It is highly desirable, but not essential, that the applicant has NetSuite and/or DemandCaster experience, training or qualification.

SKILLS AND ABILITIES:

It is essential that the postholder has excellent English communication skills, both spoken and written; essential for report writing and understanding medical regulatory standards.

• Creating, updating and maintaining medical device build specifications, designs and documentation including written specifications, labelling and User Manuals ensuring that all documentation complies with internal procedures and International Standards.
• Investigate, identify, and rectify product and process or system issues in NetSuite and DemandCaster, balancing both reactive and proactive approaches.
• Lead and manage projects implementing product changes while assessing effects from these changes and implementing necessary actions with global suppliers, warehousing and distribution partners.
• Collaborating with global suppliers to resolve design or build issues and to finalise designs for manufacture ensuring efficiency and quality.
• Conduct thorough product and manufacturing nonconformity investigations to maintain our high standards.
• Working closely and supportively with our Sales and Purchasing functions to resolve technical product questions and to specify custom, special or modified parts.