Technical Writer/Labeling

Position: Technical Writer/Labeling

Location: Pittsburgh, PA (Hybrid)

Duration: 6 to 9 months

Visa: No H1B/CPT/OPT

Interview: Phone and Video

Need Local consultants

Job Summary:

We are seeking a Labeling and Documentation Specialist with experience in high-tech and medical device industries. The ideal candidate will be responsible for developing, managing, and ensuring compliance of product labeling and documentation. This role requires strong attention to detail, regulatory knowledge, and proficiency in Microsoft Office and Adobe Creative Suite.

Key Responsibilities:

• Develop and maintain medical device labeling and documentation in compliance with industry regulations.
• Work closely with Regulatory Affairs, Quality, Engineering, and Marketing to create and update product labels, user manuals, and other technical documents.
• Ensure labeling accuracy, consistency, and compliance with FDA, EU MDR, ISO, and other regulatory standards.
• Utilize Microsoft Office Suite for documentation development and management.
• Use Adobe Creative Suite (InDesign, Acrobat Pro, Illustrator) to design and format labels, IFUs, and marketing materials (preferred).
• Collaborate with cross-functional teams to review and approve labeling content.
• Maintain proper version control and documentation records for all labeling assets.
• Assist in audits and regulatory inspections by providing necessary documentation and records.

Required Skills & Qualifications:

Experience in medical device labeling and documentation development (high-tech industry experience preferred).
Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Experience with Adobe Creative Suite (InDesign, Acrobat Pro, Illustrator) is preferred.
Understanding of FDA, EU MDR, ISO 13485, and other medical device regulatory requirements.