Senior Technical Writer

Summary

Responsible for creating clear, accurate, and compliant labeling materials such as product labels, instructions for use (IFUs), and packaging inserts.

They ensure adherence to global regulatory standards (e.g., FDA, EU MDR), collaborate with cross-functional teams (e.g., regulatory, engineering, marketing, PLM, quality), and manage the review and approval processes.

Additionally, they manage labeling documentation, track revisions, and continuously improve labeling processes to ensure quality, safety, and regulatory compliance.

Key Duties and Responsibilities (Other duties may be assigned.)

Regulatory Compliance and Documentation


* Ensure Compliance: Ensure labeling content complies with global regulatory requirements (e.g., FDA, EU MDR, ISO 13485, etc.) and meets local language and format standards.


* Stay Updated on Regulatory Changes: Stay informed about changes to relevant medical device regulations and standards and ensure that the labeling documentation reflects these changes.


* Collaborate with Regulatory Affairs and Legal Teams: Work closely with regulatory affairs, legal, and quality assurance teams to verify that labels and instructions for use meet all legal and regulatory obligations.

Writing and Editing Labeling Materials


* Develop and Write Labeling Content: Create, write, and edit high-quality, clear, concise, and accurate labeling materials for medical devices, including product labels, user manuals, instruction guides, and packaging inserts.


* Simplify Complex Information: Translate complex technical information into user-friendly language that is easily understandable for target audiences (e.g., healthcare professionals, patients).


* Ensure Consistency: Maintain consistent terminology, style, and format across all documentation, ensuring alignment with company guidelines and industry standards.

Cross-Functional Collaboration


* Collaborate with Design and Engineering Teams: Work with product development, engineering, and design teams to understand product specifications, functionality, and key messages that should be included in the labeling.


* Work with Marketing and Clinical Teams: Coordinate with marketing and clinical teams to ensure that the labeling conveys accurate and appropriate product trademarking and branding.

Labeling Review and Approval Process


* Manage Review Cycles: Lead and coordinate the review and approval process for labeling materials, ensuring that all internal stakeholders (e.g., regulatory, engineering, marketing, PLM, quality) have reviewed and signed off.


* Track Changes: Maintain and track revisions to ensure accurate and timely updates to labeling materials, ensuring that version control is in place.

Risk Management and Quality Assurance


* Identify and Address Risks: Participate in risk management activities, such as reviewing the impact of labeling on patient safety, usability, and device performance.


* Quality Control: Ensu...