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Regulatory Labeling Remote Jobs (NOW HIRING)

Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...

Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... Reviews and approves product labelling and claims for the US and EU markets. * Stays current with ...

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... Reviews and approves product labelling and claims for the US and EU markets. * Stays current with ...

Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... Reviews and approves product labelling and claims for the US and EU markets. * Stays current with ...

Manage incident reporting, recalls, labeling, and global regulatory expansion efforts DESIRED ... Flexible Remote Schedules Nashville, TN preferred, not required * Generous PTO Plans and Paid ...

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Regulatory Labeling Remote information

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How much do regulatory labeling remote jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for regulatory labeling remote in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What is the difference between Regulatory Labeling Remote vs Regulatory Documentation Specialist?

AspectRegulatory Labeling RemoteRegulatory Documentation Specialist
CredentialsRegulatory or life sciences certifications often preferredSimilar certifications, often including regulatory affairs or compliance
Work EnvironmentPrimarily remote, collaborating with cross-functional teamsTypically office-based or hybrid, with some remote options
Industry UsageCommon in pharmaceutical, medical device, and biotech industriesUsed across similar industries, focusing on documentation management
Search & ComparisonOften compared for regulatory documentation roles with similar remote optionsRelated but more focused on documentation creation and management

Regulatory Labeling Remote and Regulatory Documentation Specialist roles share overlapping credentials and industry usage. However, Regulatory Labeling Remote emphasizes remote collaboration on labeling compliance, while Regulatory Documentation Specialist focuses on managing regulatory documents, often in a hybrid or office setting.

What are some typical challenges faced by professionals in remote regulatory labeling roles, and how can they be overcome?

Remote regulatory labeling professionals often encounter challenges like coordinating across global time zones, ensuring clear communication with cross-functional teams, and staying updated on constantly evolving regulations. To overcome these, it's essential to establish strong digital communication practices, use collaborative project management tools, and dedicate time for ongoing regulatory training. Building relationships with colleagues in regulatory affairs, quality, and product management also helps streamline the review and approval process for labeling content.

What are the key skills and qualifications needed to thrive as a Regulatory Labeling Specialist (Remote), and why are they important?

To thrive as a Regulatory Labeling Specialist, you need expertise in regulatory requirements, strong attention to detail, and a background in life sciences or a related field. Familiarity with labeling management systems, regulatory submission platforms, and knowledge of global labeling regulations are typically required, often supported by certifications such as RAC (Regulatory Affairs Certification). Exceptional written communication, collaboration, and project management skills set top candidates apart. These competencies ensure accurate and compliant product labeling, helping companies meet regulatory standards and bring products to market efficiently.

What is a Regulatory Labeling Remote position?

A Regulatory Labeling Remote position involves ensuring that product labels meet all regulatory requirements set by health authorities, often for pharmaceuticals, medical devices, or food products. Professionals in this role review, develop, and maintain labeling documentation to ensure accuracy and compliance with global or regional regulations. Working remotely allows them to perform these tasks from a location outside the traditional office, using digital tools to communicate and collaborate with regulatory, legal, and product development teams. They are essential for ensuring that products can be legally marketed and used safely by consumers.
More about Regulatory Labeling Remote jobs
What cities are hiring for Regulatory Labeling Remote jobs? Cities with the most Regulatory Labeling Remote job openings:
What are the most commonly searched types of Regulatory Labeling jobs? The most popular types of Regulatory Labeling jobs are:
What states have the most Regulatory Labeling Remote jobs? States with the most job openings for Regulatory Labeling Remote jobs include:
Infographic showing various Regulatory Labeling Remote job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Advanced Specialist, Regulatory Product Strategy & Delivery (Remote)

Advanced Specialist, Regulatory Product Strategy & Delivery (Remote)

ResMed, Inc.

San Diego, CA • On-site, Remote

Full-time

Posted 7 days ago


ResMed rating

7.4

Company rating: 7.4 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

131st of 190 rated software companies


Job description

The primary role of the Regulatory Affairs function is to provide support and guidance with respect to the regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to the business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence and excellence in execution. Ensuring that systems and processes are established to enable ResMed to comply with multiple regulatory frameworks, in order to support the design, development and manufacture of products which meet our customer's quality requirements. Working closely with all internal stakeholders and external regulators to achieve business goals.
This role supports software-driven and digital health solutions, including Software as a Medical Device (SaMD) and algorithm-driven functionality (including AI/ML-enabled features), and requires experience evaluating regulated and non-regulated digital health technologies based on intended use and applicable regulatory frameworks. Acting as a regulatory partner within cross-functional teams, this role translates global regulatory requirements into clear, actionable guidance and ensures regulatory strategy is integrated across intended use, claims and labeling, design controls, change management, submission planning, and post-market compliance activities.
Let's talk about Responsibilities
  • The primary objective of Regulatory Affairs specialization within the Regulatory Affairs Job Family is to provide strategic, tactical and operational direction and support to work within regulations and expedite the development and delivery of safe and effective devices to patients globally.
  • Act as the Regulatory representative on cross-functional teams, providing strategic regulatory input for new product development, product modifications, and lifecycle management activities.
  • Maintain awareness of evolving global regulatory requirements and proactively assess regulatory impact on business strategy and product development, translating requirements into actionable regulatory strategies and recommendations.
  • Provide regulatory guidance to product development by translating regulatory requirements into clear, risk-based recommendations, including intended use, claims, product requirements, and design control activities.
  • Author and support regulatory submissions/registrations/renewals (e.g., FDA 510(k), EU MDR Technical Documentation, and other global submissions).
  • Perform regulatory assessments for product and software changes (e.g., software updates, algorithm modifications, labeling updates, and design changes), determining regulatory impact, required actions, and supporting appropriate regulatory pathway decisions.
  • Evaluate regulatory status of digital health technologies, including regulated and non-regulated software functions, and determine appropriate classification and compliance pathways.
  • Review and approve labeling, advertising, and promotional materials to ensure alignment with regulatory requirements, approved claims, and intended use.
  • Support post-market compliance activities, including regulatory inspections, audits, recalls, and collaboration with internal stakeholders and external regulatory bodies (e.g., FDA, Notified Bodies).
  • Support timely product launches and ongoing market access across regions through effective regulatory execution.
  • Participate in regulatory interactions with health authorities, including Pre-Submissions, Notified Body consultations, and responses to regulatory inquiries.
  • Network with senior internal and external personnel within the area of expertise.
  • May lead the work of project teams and formally train and mentor junior staff.

Let's talk about Qualifications and Experience
Required:
  • Bachelor's degree.
  • Minimum of 3 years of related experience in a regulated industry as a regulatory affairs professional.
  • Experience with Software as a Medical Device (SaMD) and/or digital health products.
  • Experience authoring and contributing to FDA regulatory submissions (e.g., 510(k), De Novo, or equivalent).
  • Experience working with EU MDR regulatory requirements.
  • Experience authoring regulatory assessments for product and software changes.
  • Experience authoring regulatory strategy and submissions across the product lifecycle.
  • Ability to communicate regulatory concepts effectively to both technical and non-technical stakeholders.

Preferred:
  • 5+ years of related experience in a regulated industry as a regulatory affairs professional.
  • Experience with AI/ML-enabled medical devices or algorithm-based functionality.
  • Experience working with cross-functional product development teams in regulated environments.
  • Experience supporting global regulatory submissions or market access across multiple regions.
  • Familiarity with regulatory considerations for cybersecurity, data privacy, and data governance in digital health systems.
  • Experience working in agile or software development environments.

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.

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