Technical Writer responsible for developing and maintaining regulated medical device documentation, including Instructions for Use, patient materials, and product labeling. Job Requirements Bachelor's degree in Technical Communication, English, Biomedical Engineering, Life Sciences, or a related field. 2+ years of technical writing experience in a regulated medical, medical device, or manufacturing environment. Experience creating and maintaining controlled technical documentation. Proficiency with Microsoft Office. Proficiency with Adobe Creative Cloud. Experience with content management systems and/or quality management systems. Direct experience developing medical device Instructions for Use (IFUs) and/or product labeling. Knowledge of FDA, ISO, and/or EU MDR requirements. Experience developing regulated labeling content. Experience with XML-based content management systems. Experience writing technical content for clinicians and patients. Knowledge of medical terminology and human anatomy. Experience maintaining document control and revision histories. Preferred Skills Experience supporting medical device labeling throughout the product lifecycle. Experience with risk-management documentation. Experience with structured authoring or reusable content systems. Experience supporting regulatory submissions or documentation updates. Experience developing patient-facing manuals and clinical-use documentation. Experience coordinating documentation changes across engineering, quality, clinical, regulatory, marketing, and manufacturing functions. Job Responsibilities Develop and revise Instructions for Use (IFUs), patient manuals, and product labels. Create technical content for clinician and patient audiences. Translate engineering, clinical, and product information into controlled documentation. Maintain documentation in accordance with

FDA, ISO, EU

MDR, and applicable quality system requirements. Manage document revisions, approval workflows, and revision histories. Maintain document control records and associated quality documentation. Support development and maintenance of risk-management documentation. Update labeling and IFU content based on engineering, regulatory, clinical, or manufacturing changes. Maintain content within XML-based content management systems. Coordinate documentation inputs with Engineering, Quality, Clinical, Regulatory, Marketing, and Manufacturing teams. Support multiple documentation projects and controlled release schedules.

Pay:

40-43/hr Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.