Proven expertise remediating and improving a medical device labeling process to ensure an effective, compliant, inspection-ready program. * Experience using an eQMS required; Veeva Vault preferred.
Proven expertise remediating and improving a medical device labeling process to ensure an effective, compliant, inspection-ready program. * Experience using an eQMS required; Veeva Vault preferred.
Labeling Analyst
Irving, TX · On-site
... Medical device Labeling and packaging re-design and test methods to improve label readability, barcode placement, and manufacturing efficiency -Participate in investigations related to labeling ...
Quick apply
Labeling Analyst
Irving, TX · On-site
... Medical device Labeling and packaging re-design and test methods to improve label readability, barcode placement, and manufacturing efficiency -Participate in investigations related to labeling ...
Inspect medical device labeling and medical device components. * Ensure that all material received is in compliance with all appropriate documents, policies and is delivered to the appropriate ...
Inspect medical device labeling and medical device components. * Ensure that all material received is in compliance with all appropriate documents, policies and is delivered to the appropriate ...
Labeling Work Stream Lead
Covington, GA · On-site
The WSL will be able to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR ...
Labeling Work Stream Lead
Covington, GA · On-site
The WSL will be able to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
Labeling Specialist
Moundsview, MN · On-site
This position will be a subject matter expert in Medical Device labeling regulations and standards. They will be responsible for planning, development and execution of product labeling for Medtronic ...
Labeling Specialist
Moundsview, MN · On-site
This position will be a subject matter expert in Medical Device labeling regulations and standards. They will be responsible for planning, development and execution of product labeling for Medtronic ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
The WSL will beable to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 ...
This position will be a subject matter expert in Medical Device labeling regulations and standards. They will be responsible for planning, development and execution of product labeling for Structural ...
This position will be a subject matter expert in Medical Device labeling regulations and standards. They will be responsible for planning, development and execution of product labeling for Structural ...
Medical Device Assembler
$21 - $22/hr
Medical Device Assembler The assembler works in a fast-paced medical device warehouse, handling the ... Prepare outgoing shipments by picking, packing, labeling, and staging products according to ...
Quick apply
Medical Device Assembler
$21 - $22/hr
Medical Device Assembler The assembler works in a fast-paced medical device warehouse, handling the ... Prepare outgoing shipments by picking, packing, labeling, and staging products according to ...
Regulatory Labeling Associate, Medical Device
Paramus, NJ · On-site
$45K - $60K/yr
The Regulatory Associate - Labeling is responsible for preparing labeling for medical devices in ... Device Identification Database (GUDID), EUDAMED, and other global databases, as appropriate.
Regulatory Labeling Associate, Medical Device
Paramus, NJ · On-site
$45K - $60K/yr
The Regulatory Associate - Labeling is responsible for preparing labeling for medical devices in ... Device Identification Database (GUDID), EUDAMED, and other global databases, as appropriate.
Labelling Change Manager
Irving, TX · On-site
Execute Medical device Labeling and packaging re-design and test methods to improve label readability, barcode placement, and manufacturing efficiency * Participate in investigations related to ...
Quick apply
Labelling Change Manager
Irving, TX · On-site
Execute Medical device Labeling and packaging re-design and test methods to improve label readability, barcode placement, and manufacturing efficiency * Participate in investigations related to ...
... label finished medical devices accurately • Complete production records and work order documentation while maintaining a clean work area Candidates for Medical Device Assembler must meet the ...
Quick apply
... label finished medical devices accurately • Complete production records and work order documentation while maintaining a clean work area Candidates for Medical Device Assembler must meet the ...
Be Seen First
Medical Device Assembler
Buford, GA · On-site
$17.50/hr
... labeling, and preparation of finished medical products Qualifications ● Previous assembly or manufacturing experience required ● Clean room or medical device assembly experience preferred ● ...
Quick apply
Be Seen First
Medical Device Assembler
Buford, GA · On-site
$17.50/hr
... labeling, and preparation of finished medical products Qualifications ● Previous assembly or manufacturing experience required ● Clean room or medical device assembly experience preferred ● ...
Human Factors Engineer, Biopharma Medical Device - Remote
Thousand Oaks, CA · Remote
$70 - $80/hr
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424) Location: Thousand Oaks, CA ... FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, relevant device labeling standards IEC ...
Human Factors Engineer, Biopharma Medical Device - Remote
Thousand Oaks, CA · Remote
$70 - $80/hr
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424) Location: Thousand Oaks, CA ... FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, relevant device labeling standards IEC ...
In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling, regulation and compliance. • Project Management Methodologies: Familiarity ...
Quick apply
In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling, regulation and compliance. • Project Management Methodologies: Familiarity ...
Regulatory Affairs Specialist - Labeling
Bridgewater, NJ · On-site +1
$38 - $47/hr
Perform label assessments using labeling processes, forms and checklists * Works to resolve any ... Knowledge of medical device industry regulatory affairs discipline throughout the product lifecycle ...
Regulatory Affairs Specialist - Labeling
Bridgewater, NJ · On-site +1
$38 - $47/hr
Perform label assessments using labeling processes, forms and checklists * Works to resolve any ... Knowledge of medical device industry regulatory affairs discipline throughout the product lifecycle ...
Medical Device Labeling information
See salary details
$15.82 is the 25th percentile. Wages below this are outliers.
$12.98 - $20.48
66% of jobs
$20.48 - $27.97
6% of jobs
$31.10 is the 75th percentile. Wages above this are outliers.
$27.97 - $35.47
6% of jobs
$35.47 - $42.96
7% of jobs
$42.96 - $50.46
5% of jobs
$50.46 - $57.95
5% of jobs
$57.95 - $65.45
1% of jobs
$65.45 - $72.95
0% of jobs
$72.95 - $80.44
0% of jobs
$80.44 - $87.94
1% of jobs
$87.94 - $95.43
1% of jobs
$12
$30
$95
How much do medical device labeling jobs pay per hour?
What is a Medical Device Labeling job?
What are the key skills and qualifications needed to thrive in the Medical Device Labeling position, and why are they important?
What are the typical daily responsibilities for someone working in Medical Device Labeling?
- What are the key skills and qualifications needed to thrive in the Medical Device Labeling position and why are they important?
- What are the typical daily responsibilities for someone working in Medical Device Labeling?
- What is a Medical Device Labeling job?
- The 10 Top Types Of Medical Device Labeling Jobs
- Costa Rica Medical Device Quality
- Complaint Management Medical Device
- Contract Quality Engineer Medical Device
- Quality Engineer Medical Device Entry Level
- Freelance Medical Device Labeling
- Medical Device Reporting
- Medical Device Regulatory Compliance
- Quality Inspector Medical Device
- Quality Job
- Medical Device Quality Consultant

Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 21 days ago
Job description
- 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.
- BS/BA degree & 10+ years of related experience, or Masters & 8+ years of related experience, or PhD & 5+ years of related experience.
- Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 801, 21 CFR 809, 21 CFR 820, ISO 13485:2016, ISO 14971:2019, MDR/IVDR.
- Experience establishing and implementing medical device UDI, compliant with both FDA and EU regulations."
- Proven expertise remediating and improving a medical device labeling process to ensure an effective, compliant, inspection-ready program.
- Experience using an eQMS required; Veeva Vault preferred.
- Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
- Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
- Experience supporting regulatory inspections/audits and responding to findings.
- Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides.
- Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
- Excellent written and verbal communication skills and attention to detail.
- Ability to comprehend and interpret technical information related to GRAIL's product claims.
- Experience preparing for, leading, and supporting FDA and EU Notified Body regulatory inspections/audits and effectively responding to findings.
- BS/BA degree & 12+ years of related experience
- ASQ Certified Quality Auditor, Certified Quality Engineer, or similar preferred.
- Experience working within a clinical laboratory (high complexity CLIA/CAP environment, compliant with ISO 15189) preferred.
- Next Generation Sequencing (NGS) experience preferred.
- Work performed in office, production, and laboratory environments; frequent cross-functional engagement.
- Travel may be required to support audits, inspections, or collaboration with global teams and suppliers.
- Use of PPE in production and laboratory settings may be required.
- Standard weekday schedule with flexibility for extended hours during regulatory inspections, customer visits, or critical investigations.
About Grail
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Menlo Park, CA, US
Year founded
2015