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 Work Stream Lead
Covington, GA · On-site +1
The WSL will be able to develop, design, and release medical device product labeling with the ... Remote or field-based positions will have different workplace arrangements which will be indicated ...
Labeling Work Stream Lead
Covington, GA · On-site +1
The WSL will be able to develop, design, and release medical device product labeling with the ... Remote or field-based positions will have different workplace arrangements which will be indicated ...
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 ...
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424)
Thousand Oaks, CA · Remote
$70 - $80/hr
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424) Location: Thousand Oaks, CA ... Other: HE:75, EU MDR Annex 1, additional relevant international device labeling and usability ...
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424)
Thousand Oaks, CA · Remote
$70 - $80/hr
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424) Location: Thousand Oaks, CA ... Other: HE:75, EU MDR Annex 1, additional relevant international device labeling and usability ...
Remote Medical Device Software Engineer
Manhattan, NY · On-site +1
A healthcare technology company is seeking a Medical Device Software Engineer for remote work in the US. The ideal candidate will possess at least 3 years of software engineering experience and ...
Remote Medical Device Software Engineer
Manhattan, NY · On-site +1
A healthcare technology company is seeking a Medical Device Software Engineer for remote work in the US. The ideal candidate will possess at least 3 years of software engineering experience and ...
A leading medical device company in Orlando, FL is seeking a Digital Field Service Engineer to ... This role offers remote work options and requires 50% travel. Alcon promises a robust benefits ...
A leading medical device company in Orlando, FL is seeking a Digital Field Service Engineer to ... This role offers remote work options and requires 50% travel. Alcon promises a robust benefits ...
Regulatory Affairs Specialist - Labeling
Bridgewater, NJ · On-site +1
$38 - $47/hr
Rochester, NY, Clearwater, FL, St Louis MO, or Bridgewater, NJ Remote option Length of assignment ... Knowledge of medical device industry regulatory affairs discipline throughout the product lifecycle ...
Regulatory Affairs Specialist - Labeling
Bridgewater, NJ · On-site +1
$38 - $47/hr
Rochester, NY, Clearwater, FL, St Louis MO, or Bridgewater, NJ Remote option Length of assignment ... Knowledge of medical device industry regulatory affairs discipline throughout the product lifecycle ...
A leading medical technology firm seeks an Associate Territory Manager to support cardiovascular therapies. This remote position demands strong interpersonal and technical skills to drive market ...
A leading medical technology firm seeks an Associate Territory Manager to support cardiovascular therapies. This remote position demands strong interpersonal and technical skills to drive market ...
... labeling/Instructions for Use (IFU) to ensure scientific accuracy and regulatory compliance. * Compliance Interpretation: Interpret complex medical device regulations and evolving FDA guidance to ...
Quick apply
... labeling/Instructions for Use (IFU) to ensure scientific accuracy and regulatory compliance. * Compliance Interpretation: Interpret complex medical device regulations and evolving FDA guidance to ...
Medical Device Sales Representative
San Francisco, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
San Francisco, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
San Mateo, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
San Mateo, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Alameda, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Alameda, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Sonoma, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Sonoma, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Hayward, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Hayward, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Fremont, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Fremont, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
San Jose, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
San Jose, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Sunnyvale, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Sunnyvale, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Santa Rosa, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Santa Rosa, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Mundelein, IL · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Mundelein, IL · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Santa Clara, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Medical Device Sales Representative
Santa Clara, CA · Remote
$75K/yr
Remote (preferably northern California) Hire Type: Full-Time, Remote Compensation: $75K/year target ... Proven B2B sales experience (medical device experience preferred) * Experience managing a mix of ...
Remote Medical Device Labeling information
See salary details
$12.98 - $14.16
1% of jobs
$14.16 - $15.34
1% of jobs
$15.34 - $16.52
7% of jobs
$17.49 is the 25th percentile. Wages below this are outliers.
$16.52 - $17.70
19% of jobs
The median wage is $18.67 / hr.
$17.70 - $18.88
26% of jobs
$18.88 - $20.06
14% of jobs
$20.80 is the 75th percentile. Wages above this are outliers.
$20.06 - $21.24
11% of jobs
$21.24 - $22.42
7% of jobs
$22.42 - $23.60
6% of jobs
$23.60 - $24.78
5% of jobs
$24.78 - $25.96
2% of jobs
$12
$19
$25
How much do remote medical device labeling jobs pay per hour?
What is the difference between Remote Medical Device Labeling vs Medical Device Quality Assurance Specialist?
| Aspect | Remote Medical Device Labeling | Medical Device Quality Assurance Specialist |
|---|---|---|
| Credentials | Regulatory knowledge, labeling certifications | Quality standards, compliance certifications |
| Work Environment | Remote, documentation-focused | Office or manufacturing settings, audits |
| Industry Usage | Regulatory submissions, labeling compliance | Product quality, process improvement |
Remote Medical Device Labeling focuses on ensuring product labels meet regulatory standards, often working remotely on documentation. Medical Device Quality Assurance Specialists concentrate on maintaining product quality and compliance through audits and process controls, typically working in physical environments. Both roles are essential in the medical device industry but differ in their primary focus and work settings.
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Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 19 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