Jobs and Careers
GR
Associate Director, Medical Device Labeling and UDI # 4648
GRAILUnited Statesfull_timeVerifiedPosted 10 Mar 2026
💰 $194,000/yr($146,000/yr – $194,000/yr)
About the role
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com
The Associate Director, Quality Labeling Operations is responsible for establishing, implementing, maintaining, and continuously improving GRAIL’s product labeling program. This role partners closely with Regulatory Affairs, Operations, Marketing, Supply Chain, R&D, Clinical Laboratory, Clinical Operations, and Design/Artwork to lead the global product labeling controls for GRAIL’s regulated in vitro diagnostic (IVD) medical devices. This individual contributor role is the SME responsible for the development, implementation, and lifecycle management of compliant product labeling content, including Instructions for Use (IFU), Unique Device Identifier (UDI) labeling, and other product labeling elements required under FDA, EU IVDR/MDR, and U.K. MHRA regulations. The individual applies critical thinking and sound judgment to solve broad, complex problems and regularly communicates status, risks, and recommendations to management. Primary responsibilities include providing expertise and oversight to ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485:2016, ISO 14971:2019, 21 CFR 801, 21 CFR 820, 21 CFR 809, Unique Device Identifier (UDI) requirements and related in vitro diagnostic medical device regulations. This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com
The Associate Director, Quality Labeling Operations is responsible for establishing, implementing, maintaining, and continuously improving GRAIL’s product labeling program. This role partners closely with Regulatory Affairs, Operations, Marketing, Supply Chain, R&D, Clinical Laboratory, Clinical Operations, and Design/Artwork to lead the global product labeling controls for GRAIL’s regulated in vitro diagnostic (IVD) medical devices. This individual contributor role is the SME responsible for the development, implementation, and lifecycle management of compliant product labeling content, including Instructions for Use (IFU), Unique Device Identifier (UDI) labeling, and other product labeling elements required under FDA, EU IVDR/MDR, and U.K. MHRA regulations. The individual applies critical thinking and sound judgment to solve broad, complex problems and regularly communicates status, risks, and recommendations to management. Primary responsibilities include providing expertise and oversight to ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485:2016, ISO 14971:2019, 21 CFR 801, 21 CFR 820, 21 CFR 809, Unique Device Identifier (UDI) requirements and related in vitro diagnostic medical device regulations. This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.
Responsibilities:
- Serve as the primary process owner for product labeling operations activities within the Quality Management System (QMS).Establish, maintain, and improve product labeling processes, procedures, and infrastructure (including electronic labeling systems, proofing, and physical and electronic distribution controls).
- Establish and maintain labeling specifications and source artwork files (printed and electronic).
- Ensure all product label claims are substantiated through the Design History File in partnership with Regulatory, Design Quality, and Research, Design, and Operations teams.
- Partner with Marketing and Regulatory teams to align product labeling controls with advertising/promotional labeling controls, which are managed by the Promotional Material Review Committee and led by Marketing.
- Initiate and support Veeva change control workflows for product labeling specifications which evaluate design history file (DHF) and risk management file (RMF) impacts.
- Maintain inspection-ready product labeling documentation and traceability between product labeling, risk files, and technical documentation.
- Ensure only current, approved product labels are distributed in print and electronically.
- Drive cross-functional alignment and governance for labeling, ensuring Regulatory, Legal, and Clinical Study content oversight and compliant execution.
- Manage label verification and validation, including proof review, barcode functionality, and compliance with UDI, GUDID, and GS1 requirements.
- Provide direction to cross-functional teams on product labeling compliance requirements.
- Align global core product labeling with regional requirements while supporting local adaptations for major markets.
- Represent the Product Labeling Program as Subject Matter Expert during audits and inspections.
- Monitor global regulatory changes and lead labeling process updates to maintain compliance that is aligned with our Commercial strategy.
Required Qualifications:
- BS/BA degree & 10+ years of related experience, or Masters &a
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s