Technical Writer

Experience working in a regulated industry such as medical devices or pharmaceuticals.

Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.

Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers.

Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation.

Ability to demonstrate a high level of initiative to gather information for developing documentation.

Ability to work independently with minimal supervision.

Effective at thinking independently and solving problems with product core team members.

Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events.

Ability to handle multiple projects with excellent follow-up and project management skills.

Familiarity with electro-mechanical concepts and software application usage.

Experience in device labeling and/or packaging content development.

Familiarity with large company engineering change control processes and Agile software development methodologies.

• Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system is a plus.