Sr. Technical Writer

As a Senior Technical Writer, you will support the development of customer-facing product labeling for a medical device line. The labeling may include: instructions for use (IFU), manuals, user guides, device labels, and package labels. You may also work on marketing materials and medical literature. In addition to the labeling itself, you will be accountable for labeling supporting documentation, which may include design plans, requirements documents, review reports, and verification reports. You will directly support R&D projects for both new product development and released product maintenance.
We are seeking a highly independent, self-driven, and accountable technical writer with prior experience with medical device labeling and the regulatory process, who requires minimal supervision.

• Set the strategy and develop plans for projects impacting the labeling for this product line.
• Collaborate with departmental and cross-functional stakeholders and subject matter experts to develop the labeling content and resolve issues as they arise during the development process.
• Ensure compliance of labeling with all applicable regulatory (e.g., FDA, EU MDR, ISO standards, etc.) and quality requirements.
• Write and produce documentation that conforms to quality management system requirements.
• Produce and/or edit graphics, illustrations, and charts that are included within the labeling materials.
• Communicate project status and risks to program, functional, and business leaders.
• Provide input to project schedule development.
• Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.

• Advanced knowledge of the job area (breadth and depth), typically through advanced education plus experience.
• May have practical project management knowledge.
• Education/experience requirement: Baccalaureate degree (or qualifying foreign equivalent under 8 C.F.R. § 214.2(h)(4)(iii)(A)) and a minimum of 4 years relevant experience, or an advanced degree with a minimum of 2 years relevant experience.