Regulatory Tech Writer & Labeling Designer

Medtronic; Irvine (CA); On-site; USD 68,000 - 102,000; Full time

Job summary

Medtronic Irvine, CA is seeking a Tech comm Specialist/ Writer to develop labeling and regulatory documentation for Neurovascular products. You will define labeling strategy, manage translation, and oversee PLM changes while ensuring compliance with 21 CFR, EU MDR, ISO standards and Medtronic quality systems.

The role requires at least 2 years in regulatory/product compliance, labeling, or technical writing in medical devices, with strong written communication skills and the ability to work

Qualifications

• Requires a Baccalaureate degree.
• Minimum of 2 years of regulatory/product compliance, labeling, technical writing, or technical editing experience in the medical devices industry.

Responsibilities

• Develop, maintain, and release labeling and technical documentation for Neurovascular products.
• Collaborate with product development and cross-functional partners to define labeling strategy.
• Coordinate translation projects and manage translation requirements.
• Handle change control and admin tasks in a Product Lifecycle Management system.
• Apply US/EU regulations (21 CFR, EU MDR, ISO standards) and quality systems.
• Perform quality checks and proofreading of artworks.
• Manage documentation in a matrixed environment and prioritize tasks.
• Travel domestically and internationally as needed (<10%).

Skills

Regulatory compliance

Technical writing

Labeling

Technical editing

Education

Baccalaureate degree

Job description

Medtronic Irvine, CA is seeking a Tech comm Specialist/ Writer to develop labeling and regulatory documentation for Neurovascular products. You will define labeling strategy, manage translation, and oversee PLM changes while ensuring compliance with 21 CFR, EU MDR, ISO standards and Medtronic quality systems.

The role requires at least 2 years in regulatory/product compliance, labeling, or technical writing in medical devices, with strong written communication skills and the ability to work