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Medical Device Labeling Jobs (NOW HIRING)

Noah Medical

Sr. RA Specialist

San Jose, CA · Hybrid

FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements * Regulatory Affairs ...

Noah Medical

Sr. RA Specialist

San Jose, CA · On-site

FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements * Regulatory Affairs ...

Artivion

Labeling Specialist

Kennesaw, GA · Hybrid

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on ... Ensure labels comply with internal standards and applicable regulatory requirements * Coordinate ...

CryoLife

Labeling Specialist

Kennesaw, GA · On-site

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on ... Ensure labels comply with internal standards and applicable regulatory requirements * Coordinate ...

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Medical Device Labeling information

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How much do medical device labeling jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for medical device labeling in the United States is $30.53, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $39.18 per hour, depending on experience, location, and employer.

What is a medical device labeling?

A Medical Device Labeling job involves creating, reviewing, and managing labeling content for medical devices to ensure compliance with regulatory requirements. This includes instructions for use, packaging labels, and safety information for healthcare professionals and patients. Professionals in this role collaborate with regulatory, quality, and engineering teams to meet industry standards and country-specific regulations. Their work ensures that medical devices are used safely and effectively, reducing risks associated with improper usage.

What are the key skills and qualifications needed to thrive in medical device labeling?

To thrive in Medical Device Labeling, you need a strong understanding of regulatory requirements (such as FDA and EU MDR), attention to detail, and experience with technical writing or documentation, often supported by a degree in life sciences or a related field. Familiarity with labeling management systems, document control tools, and knowledge of ISO standards are key technical qualifications, and certifications like RAC can be advantageous. Strong communication, collaboration, and organizational skills set candidates apart, as these roles often involve coordinating with cross-functional teams such as regulatory, engineering, and quality assurance. These capabilities ensure labeling materials meet strict compliance standards, avoid costly errors or recalls, and support timely product launch and patient safety.

What does a medical device labeling do?

Professionals in Medical Device Labeling are responsible for creating, reviewing, and updating product labels, instructions for use, and packaging materials to ensure compliance with regulatory standards. They often collaborate closely with regulatory affairs, engineering, and quality assurance teams to gather technical product information and incorporate feedback. Daily activities may also include managing document control processes, implementing labeling changes driven by new regulations or product updates, and preparing submissions for global markets. Attention to detail and the ability to manage multiple projects simultaneously are crucial for success in this role.

More about Medical Device Labeling jobs
What cities are hiring for Medical Device Labeling jobs? Cities with the most Medical Device Labeling job openings:
What are the most commonly searched types of Medical Device Labeling jobs? The most popular types of Medical Device Labeling jobs are:
What states have the most Medical Device Labeling jobs? States with the most job openings for Medical Device Labeling jobs include:
What job categories do people searching Medical Device Labeling jobs look for? The top searched job categories for Medical Device Labeling jobs are:
Medical Device Labeling jobs near you
Infographic showing various Medical Device Labeling job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $63,493 per year, or $30.5 per hour.

Regulatory Affairs Specialist / Medical Devices / Hybrid Work

Pioneer Data

West Chester, PA • On-site

Contractor

Re-posted 20 days ago

Job description

Position Details:
Our client, a world-leading Pharmaceutical Company in West Chester, PA is currently looking for a Regulatory Affairs Specialist to join their expanding team.  
 
Job Title: Regulatory Affairs Specialist / Medical Devices / Hybrid Work
Duration: 7 months contract, extendable up to 24 Months
Location: West Chester, PA 
Role will be located in PA, will be HYBRID, must be able to come to the local PA office when needed
 
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan  
 
Job Description:
Position Job Title: Sr. RA Specialist
 
Notes:
Role will be located in PA, will be HYBRID, must be able to come to the local PA office when needed
Bachelor's degree is required
Must have 4-6 years of experience in Regulatory Affairs
Must have prior experience in supporting the Regulatory teams
Must be able to multi-task
Must have Regulatory experience
Must be able to handle Regulatory submissions
Section 1: Job Summary
Prepare regulatory documentation to support the market distribution of new and modified
medical devices (510(k)/NTF) in US, Canada, and EU. 
Support global registrations in rest of
world. Review device labeling, including all graphic material. 
Prepare export certificates, medical device listings, annual establishment registrations for submission to the U.S. Food and Drug Administration (FDA). 
Assist group in maintaining regulatory databases for all products. 
Provide support to Regulatory Manager for special projects as needed.
 
Section 2: Duties & Responsibilities
In accordance with all applicable federal, state and local laws/regulations and Corporate
Client, procedures and guidelines, this position:
Compile, prepare, review and submit regulatory submission to regulatory authorities
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices
Interface with Product Development to obtain necessary information for regulatory submissions
Review/approve Custom Device Requests
Review/approve Engineering Change Requests/Notices
Prepare export certificates, medical device listings, and annual establishment registrations
Respond to requests for information on import detentions
Maintain regulatory database - ongoing update of database with regulatory information
Assist in the development and implementation of SOPs and systems to track and manage
product-associated events
Assist in the development of regulatory strategy and update strategy based upon regulatory changes
Provide regulatory input to product lifecycle planning
Evaluate regulatory impact on proposed products
Understand, investigate and evaluate regulatory history/background of class,
disease/therapeutic/diagnostic context in order to assess regulatory implications for approval
Determine and communicate submission and approval requirements
Begin to participate in risk-benefit analysis for regulatory compliance
Submit and review change controls to determine the level of change and consequent
submission requirements
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
Provide training for staff on current and new regulatory requirements
Communicate regulatory agency/industry positions within the regulatory department
Problem-solve with and advise internal stakeholders on regulatory issues
Identify standards for the organization’s products
Participate in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Review/approve labeling: device labels, brochures, technique guides, bulletins, updates,
etc. Responsible for communicating business related issues or opportunities to next
management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
 
Section 3: Experience And Education
BS Degree in Science or Engineering required
Four to six years related regulatory experience in medical devices or relevant medical device industry experience
 
Section 4: Required Knowledge, Skills, Abilities, Certifications/Licenses And Affiliations
Excellent written and oral communication skills
Excellent organizational skills preferred
Ability to handle multiple tasks and be detail oriented
Ability to apply risk-benefit analysis techniques
General knowledge of Submission types and requirements
Knowledge of clinical research, clinical operations, and nonclinical, quality, and regulatory requirements and GxPs (GCPs, GLPs, GMPs)