Quality Compliance/Labeling Specialist (Medical Device)
Quality Assurance, Compliance / Regulatory
Mountain View, CA, USA
Posted on Jun 21, 2026
Seeking a Quality Compliance/Labeling Specialist to support global medical device labeling, Instructions for Use (IFU), and regulatory compliance activities. Key responsibilities include developing and maintaining compliant IFUs, reviewing and approving product labels, managing marketing claims, and ensuring documentation meets international standards. The role involves collaborating with Regulatory Affairs, Quality, Engineering, and Marketing teams to incorporate country-specific requirements and participate in design and change control processes. Candidates should have a bachelor’s degree or equivalent, 2-5 years of experience in medical device labeling, and strong knowledge of global regulations such as 21 CFR 801 and EU MDR. Excellent communication, organization, and cross-functional teamwork skills are essential. Technical writing experience is preferred. The position offers competitive pay and benefits, supporting career growth in a regulated life sciences environment.