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Freelance Medical Device Labeling Jobs (NOW HIRING)

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 ...

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 ...

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Freelance Medical Device Labeling information

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$14

$47

$132

How much do freelance medical device labeling jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for freelance medical device labeling in the United States is $47.71, according to ZipRecruiter salary data. Most workers in this role earn between $24.28 and $61.78 per hour, depending on experience, location, and employer.

What is freelance medical device labeling?

Freelance medical device labeling involves independent professionals who create, review, and manage the labels and instructions that accompany medical devices. These labels must meet strict regulatory requirements to ensure patient safety and regulatory compliance. Freelance specialists may work with manufacturers to develop compliant packaging, user manuals, and product inserts for various markets. They need to be knowledgeable about international regulations and guidelines, such as those from the FDA or the European MDR. This role often requires attention to detail, regulatory expertise, and clear communication skills.

What are the key skills and qualifications needed to thrive as a freelance medical device labeling specialist?

To thrive as a Freelance Medical Device Labeling Specialist, you need expertise in regulatory requirements, medical terminology, and technical writing, often supported by a background in life sciences or regulatory affairs. Familiarity with labeling management systems, document control software, and knowledge of FDA, EU MDR, or ISO standards is typically required. Attention to detail, strong organizational skills, and clear communication are essential soft skills to ensure accuracy and compliance. These skills are critical for producing precise, regulation-compliant labeling that ensures patient safety and successful product approval.

What are some common challenges freelance medical device labeling specialists face when collaborating with multiple clients?

Freelance medical device labeling specialists often navigate varying regulatory requirements and documentation standards from different clients, which can be challenging. Each client may use different systems for document management and have unique internal review processes, requiring adaptability and strong organizational skills. Additionally, balancing multiple projects with tight deadlines demands effective time management to ensure all labeling materials remain compliant and up to date. Proactive communication and a thorough understanding of regional regulations are crucial for successful collaboration and project delivery.
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Infographic showing various Freelance Medical Device Labeling job openings in the United States as of August 2026, with employment types broken down into 50% Full Time, 44% Contract, and 6% Nights. Highlights an 100% In-person job distribution, with an average salary of $99,230 per year, or $47.7 per hour.

Principal Regulatory Affairs Specialist - Bracco Medical Technologies

Bracco-Medical-Technologies

Eden Prairie, MN โ€ข On-site

$131 - $143/hr

Other

Medical, Retirement, PTO

Posted 10 days ago


Job description

Why Join Bracco Medical Technologies?We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!About the RoleThe Principal Regulatory Affairs Specialist develops and executes regulatory strategies for medical device products, submissions, and lifecycle changes. This role provides hands-on regulatory support for new product marketing submissions, changes to existing devices, global registrations, audits, labeling, and ongoing compliance with applicable regulations and company standards.What Youโ€™ll DoDevelop and execute regulatory plans for product submissions, including 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and select Japan/China submission content.Serve as the regulatory representative on cross-functional project teams throughout the product lifecycle, providing strategic guidance on global regulatory requirements.Prepare for and support communications with regulatory agencies and Notified Bodies, including FDA interactions, submission reviews, approvals, audits, and inspections.Maintain complete and current regulatory files, product registrations, and supporting documentation.Review device labeling, advertising, and promotional materials for compliance with approved submissions and applicable global regulations.Monitor new and changing regulations, assess business impact, and recommend appropriate compliance actions.Mentor junior regulatory staff and provide regulatory guidance to cross-functional partners.What Youโ€™ll BringBachelorโ€™s degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical field.7+ years of regulatory affairs experience in the medical device industry.Demonstrated experience preparing and supporting global regulatory submissions, including FDA 510(k), EU MDR/CE Marking, and Health Canada submissions.Strong understanding of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle requirements, labeling review, and regulatory compliance practices.Experience leading or supporting FDA meetings, agency interactions, audits, inspections, and cross-functional regulatory strategy discussions.Excellent technical writing, communication, project leadership, analytical thinking, and stakeholder management skills.Preferred QualificationsExperience supporting Class II medical devices, global market expansion, or multi-region regulatory submissions.Experience mentoring regulatory professionals or leading regulatory workstreams without direct supervisory authority.Regulatory Affairs Certification or advanced degree in a relevant discipline.Compensation & Total RewardsThe estimated base salary range for this position is $131,000โ€“$143,000 annually. Actual compensation may vary based on relevant experience, skills, education, internal equity, and business needs. Bracco Medical Technologies also offers a comprehensive total rewards package, including health benefits, paid time off, company holidays, paid family leave, retirement savings, tuition reimbursement, and professional development opportunities.Join UsIf you are a seasoned regulatory affairs professional who enjoys shaping global regulatory strategy, partnering across technical teams, and supporting meaningful medical technology innovation, we invite you to apply.Bracco Medical Technologies is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, national origin, disability, protected veteran status, age, or any other characteristic protected by applicable law. #J-18808-Ljbffr