Review and approve labeling, advertising, and promotional materials to ensure alignment with regulatory requirements, approved claims, and intended use. * Support post-market compliance activities ...
Review and approve labeling, advertising, and promotional materials to ensure alignment with regulatory requirements, approved claims, and intended use. * Support post-market compliance activities ...
Ensure alignment between clinical data, labeling, and regulatory claims. Post-Market Compliance ... Remote work possible; travel as required for clinical and regulatory activities. 120K - 150K base ...
Ensure alignment between clinical data, labeling, and regulatory claims. Post-Market Compliance ... Remote work possible; travel as required for clinical and regulatory activities. 120K - 150K base ...
Director US Regulatory Strategy
Deerfield, IL · Remote
$200K - $235K/yr
Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...
Director US Regulatory Strategy
Deerfield, IL · Remote
$200K - $235K/yr
Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...
Regulatory Affairs Manager
Milford, DE · On-site +1
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 ...
Regulatory Affairs Manager
Milford, DE · On-site +1
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 ...
Regulatory Affairs Manager
Johnson City, TN · On-site +1
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 ...
Regulatory Affairs Manager
Johnson City, TN · On-site +1
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 ...
Regulatory Affairs Manager
Charlotte, NC · On-site +1
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 ...
Regulatory Affairs Manager
Charlotte, NC · On-site +1
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 ...
Director US Regulatory Strategy
Deerfield, IL · Remote
$200K - $235K/yr
Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...
Director US Regulatory Strategy
Deerfield, IL · Remote
$200K - $235K/yr
Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...
Regulatory Affairs Manager
York, PA · On-site +1
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 ...
Regulatory Affairs Manager
York, PA · On-site +1
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 ...
Regulatory Affairs Manager
Sarasota, FL · On-site +1
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 ...
Regulatory Affairs Manager
Sarasota, FL · On-site +1
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 ...
Regulatory Affairs Manager
Charlotte, NC · On-site +1
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 ...
Regulatory Affairs Manager
Charlotte, NC · On-site +1
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 ...
Senior Regulatory & Scientific Affairs Specialist (Remote)
Arlington, VA · On-site +1
$99K - $130K/yr
Communicate relevant regulatory trends such as nutrition, foods and food standards, and labeling as well as early warning of potential regulatory events and potential impact to the Nestle portfolio.
Senior Regulatory & Scientific Affairs Specialist (Remote)
Arlington, VA · On-site +1
$99K - $130K/yr
Communicate relevant regulatory trends such as nutrition, foods and food standards, and labeling as well as early warning of potential regulatory events and potential impact to the Nestle portfolio.
Director US Regulatory Strategy
Deerfield, IL · Remote
$200K - $235K/yr
Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...
Director US Regulatory Strategy
Deerfield, IL · Remote
$200K - $235K/yr
Remote/Commuter Opportunity - Open to candidates within the United States The Director, US ... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ...
Regulatory Affairs Manager
Waltham, MA · On-site +1
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 ...
Regulatory Affairs Manager
Waltham, MA · On-site +1
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 ...
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 ...
Senior Regulatory & Scientific Affairs Specialist (Remote)
Arlington, VA · On-site +1
$99K - $130K/yr
Communicate relevant regulatory trends such as nutrition, foods and food standards, and labeling as well as early warning of potential regulatory events and potential impact to the Nestlé portfolio.
Senior Regulatory & Scientific Affairs Specialist (Remote)
Arlington, VA · On-site +1
$99K - $130K/yr
Communicate relevant regulatory trends such as nutrition, foods and food standards, and labeling as well as early warning of potential regulatory events and potential impact to the Nestlé portfolio.
Regulatory Affairs Manager
$125K - $150K/yr
Manage incident reporting, recalls, labeling, and global regulatory expansion efforts DESIRED ... Flexible Remote Schedules Nashville, TN preferred, not required * Generous PTO Plans and Paid ...
Regulatory Affairs Manager
$125K - $150K/yr
Manage incident reporting, recalls, labeling, and global regulatory expansion efforts DESIRED ... Flexible Remote Schedules Nashville, TN preferred, not required * Generous PTO Plans and Paid ...
Senior Manager Regulatory Strategy
Deerfield, IL · On-site +1
Remote/Commuter Opportunity - Open to candidates within the United States SUMMARY: The Senior ... Assesses scientific data for proposed registration and labeling against current FDA guidance ...
Senior Manager Regulatory Strategy
Deerfield, IL · On-site +1
Remote/Commuter Opportunity - Open to candidates within the United States SUMMARY: The Senior ... Assesses scientific data for proposed registration and labeling against current FDA guidance ...
Senior Manager Regulatory Strategy
Deerfield, IL · On-site +1
Remote/Commuter Opportunity - Open to candidates within the United States SUMMARY: The Senior ... Assesses scientific data for proposed registration and labeling against current FDA guidance ...
Senior Manager Regulatory Strategy
Deerfield, IL · On-site +1
Remote/Commuter Opportunity - Open to candidates within the United States SUMMARY: The Senior ... Assesses scientific data for proposed registration and labeling against current FDA guidance ...
This includes understanding and interpreting local laws related to product registration, labeling ... Fast learning skills JOB REQUIREMENTS * Full-Time * Once-weekly remote work for eligible employees
This includes understanding and interpreting local laws related to product registration, labeling ... Fast learning skills JOB REQUIREMENTS * Full-Time * Once-weekly remote work for eligible employees
Senior Manager, Regulatory Affairs
New York, NY · On-site +1
This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ ... Review and approval of product labeling and promotional and advertisement brochures and multimedia ...
Senior Manager, Regulatory Affairs
New York, NY · On-site +1
This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ ... Review and approval of product labeling and promotional and advertisement brochures and multimedia ...
Regulatory Labeling Remote information
See salary details
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
How much do regulatory labeling remote jobs pay per hour?
What is the difference between Regulatory Labeling Remote vs Regulatory Documentation Specialist?
| Aspect | Regulatory Labeling Remote | Regulatory Documentation Specialist |
|---|---|---|
| Credentials | Regulatory or life sciences certifications often preferred | Similar certifications, often including regulatory affairs or compliance |
| Work Environment | Primarily remote, collaborating with cross-functional teams | Typically office-based or hybrid, with some remote options |
| Industry Usage | Common in pharmaceutical, medical device, and biotech industries | Used across similar industries, focusing on documentation management |
| Search & Comparison | Often compared for regulatory documentation roles with similar remote options | Related 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?
What are the key skills and qualifications needed to thrive as a Regulatory Labeling Specialist (Remote), and why are they important?
What is a Regulatory Labeling Remote position?
- Chemical Regulatory Affairs
- International Regulatory Affairs Specialist
- Remote Regulatory Affairs Cosmetics
- Nutrition Regulatory Affairs
- Regulatory Affairs Assistant
- Global Regulatory Affairs Specialist
- Director Regulatory Affairs Cosmetics
- Regulatory
- Regulatory Affairs Food Supplements
- International Affairs Specialist

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
Based on 15 frontline employees who took The Breakroom Quiz
131st of 190 rated software companies
Job description
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.
About ResMed
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
5,001 - 10,000 Employees
Headquarters location
San Diego, CA, US
Year founded
1989