Advanced Specialist, Regulatory Product Strategy & Delivery (Remote)

📍 Job Overview

Job Title: Advanced Specialist, Regulatory Product Strategy & Delivery (Remote)

Company: ResMed

Location: US Field Non-Sales (Remote Workforce)

Job Type: FULL_TIME

Category: Regulatory Affairs / Product Strategy

Date Posted: April 09, 2026

Experience Level: 2-5 Years

Remote Status: Fully Remote

🚀 Role Summary

• Spearhead regulatory strategy and execution for ResMed's innovative software-driven and digital health solutions, including Software as a Medical Device (SaMD) and AI/ML-enabled features.

• Act as a critical regulatory partner within cross-functional product development teams, translating complex global regulatory requirements into actionable guidance and integrated strategies.

• Drive compliance and expedite the delivery of safe and effective medical devices to patients worldwide by ensuring adherence to diverse regulatory frameworks.

• Manage the regulatory lifecycle of products, from initial planning and design controls through submission, market access, and post-market surveillance.

📝 Enhancement Note: This role is specifically focused on the unique regulatory challenges of digital health and SaMD. The "Advanced Specialist" title, combined with the requirement for 3+ years of experience and preferred 5+ years, suggests a mid-level to senior individual contributor role. The emphasis on AI/ML and algorithm-driven functionality indicates a forward-looking position at the intersection of medical device regulation and cutting-edge technology.

📈 Primary Responsibilities

• Serve as the primary Regulatory Affairs representative on cross-functional teams, providing strategic regulatory input for new product development, product modifications, and ongoing lifecycle management activities.

• Proactively monitor and assess the impact of evolving global regulatory requirements on business strategy and product development, translating these into actionable regulatory strategies and recommendations.

• Provide clear, risk-based regulatory guidance to product development teams, covering intended use, claims, product requirements, and design control activities.

• Author and support the preparation of regulatory submissions, registrations, and renewals for key global markets, such as FDA 510(k)s, EU MDR Technical Documentation, and other international filings.

• Conduct thorough regulatory assessments for product and software changes, including software updates, algorithm modifications, labeling adjustments, and design changes, to determine regulatory impact and appropriate pathways.

• Evaluate the regulatory classification and compliance pathways for digital health technologies, encompassing both regulated and non-regulated software functions.

• Review and approve labeling, advertising, and promotional materials to ensure strict alignment with regulatory requirements, approved claims, and intended use.

• Support robust post-market compliance activities, including regulatory inspections, audits, recall management, and effective collaboration with internal stakeholders and external regulatory bodies like the FDA and Notified Bodies.

• Facilitate timely product launches and sustained market access across various regions through meticulous and effective regulatory execution.

• Participate actively in regulatory interactions with health authorities, including Pre-Submissions, Notified Body consultations, and timely responses to regulatory inquiries.

• Network and build relationships with senior internal and external personnel within the regulatory affairs domain.

• Potentially lead project teams and formally train and mentor junior regulatory affairs staff.

📝 Enhancement Note: The responsibilities highlight a strategic and execution-oriented role. Key areas include proactive regulatory intelligence, translating requirements into actionable strategies, and hands-on submission work. The emphasis on SaMD, AI/ML, and digital health technologies means candidates must understand the nuances of regulating software and algorithms, which differ significantly from traditional hardware-based medical devices.

🎓 Skills & Qualifications

Education:

Experience:

• A minimum of 3 years of related experience in a regulated industry, specifically within a Regulatory Affairs professional capacity.

• Demonstrated experience with Software as a Medical Device (SaMD) and/or digital health products is essential.

• Proven experience authoring and contributing to U.S. Food and Drug Administration (FDA) regulatory submissions, such as 510(k)s, De Novo applications, or equivalent.

• Hands-on experience working with European Union Medical Device Regulation (EU MDR) requirements is a prerequisite.

• Experience in performing regulatory assessments for product and software changes is mandatory.

• Demonstrated ability to author comprehensive regulatory strategies and submissions across the entire product lifecycle.

Required Skills:

• Regulatory Affairs Expertise: Deep understanding of global medical device regulations, with a strong focus on FDA and EU MDR.

• SaMD & Digital Health Acumen: Proven knowledge and practical experience with Software as a Medical Device principles and digital health technologies.

• Submission Authoring: Proficiency in preparing and contributing to regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation).

• Regulatory Strategy Development: Ability to define and implement effective regulatory strategies aligned with product development and business objectives.

• Cross-functional Collaboration: Skill in partnering effectively with R&D, product management, marketing, and other teams.

Preferred Skills:

• 5+ years of progressive experience in Regulatory Affairs within a regulated industry.

• Direct experience with AI/ML-enabled medical devices or complex algorithm-based functionality.

• Experience collaborating closely with cross-functional product development teams in highly regulated environments.

• Proven track record of supporting global regulatory submissions or achieving market access across multiple international regions.

• Familiarity with regulatory considerations for cybersecurity, data privacy, and data governance within digital health systems.

• Experience working within agile development methodologies or software development environments.

📝 Enhancement Note: The "Required" skills strongly emphasize hands-on experience with SaMD, FDA 510(k), and EU MDR. The "Preferred" skills point towards candidates who can handle more complex, cutting-edge digital health technologies (AI/ML) and have broader global experience, suggesting a pathway for growth within the role or team. The required bachelor's degree is standard for this field, but the specific experience requirements are critical.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Regulatory Strategy Case Studies: Showcase examples of developing and implementing regulatory strategies for novel digital health products or SaMD, detailing the rationale and anticipated outcomes.

• Submission Documentation Examples: Provide redacted samples or detailed descriptions of contributions to FDA 510(k)s, EU MDR Technical Documentation, or other global submissions, highlighting your specific role and impact.

• Regulatory Assessment Documentation: Include examples of how you've assessed product/software changes, outlining the process, decision-making criteria, and regulatory impact determination.

• Lifecycle Management Projects: Demonstrate experience managing regulatory aspects across the product lifecycle, from initial concept through post-market surveillance, emphasizing process optimization and compliance.

Process Documentation:

• Workflow Design & Optimization: Evidence of designing or optimizing regulatory workflows for product development, change control, or submission processes, focusing on efficiency and compliance.

• Implementation & Automation: Examples of implementing new regulatory processes or leveraging tools to automate regulatory tasks, such as submission tracking or compliance checks.

• Measurement & Performance Analysis: Showcase how you have measured the effectiveness of regulatory processes, using key performance indicators (KPIs) to drive continuous improvement and demonstrate ROI.

📝 Enhancement Note: For a Regulatory Affairs role, especially one focused on strategy and delivery, a portfolio demonstrating practical application of regulatory knowledge is crucial. Candidates should prepare to showcase their ability to translate regulations into tangible processes and documentation that support product development and market access. Emphasis should be on the 'how' and 'why' behind their regulatory decisions and process implementations.

💵 Compensation & Benefits

Salary Range:

Benefits:

• Comprehensive Health Insurance: Medical, dental, and vision coverage with robust plans designed to support employee well-being.

• Retirement Savings Plan: 401(k) plan with company match to support long-term financial goals.

• Paid Time Off: Generous vacation, sick leave, and holiday policies to ensure work-life balance.

• Professional Development: Opportunities for continued learning, training, certifications, and conference attendance to stay current in the rapidly evolving regulatory landscape.

• Remote Work Support: Resources and potential stipends to ensure a productive and comfortable home office environment.

• Life and Disability Insurance: Provided coverage to offer financial security.

Working Hours:

• Standard full-time hours, typically 40 hours per week. The role's remote nature offers flexibility in scheduling, allowing for adaptation to different time zones and personal needs, provided core business hours and team collaboration needs are met.

📝 Enhancement Note: As ResMed is a global medical device company, it's expected they offer a comprehensive benefits package. The salary range is an estimate derived from industry data for similar roles in the US, adjusted for a remote position and the specified experience level. The focus on digital health and SaMD may command salaries towards the higher end of this range.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Devices & Healthcare Technology. ResMed is a leader in developing cloud-connected devices and software for managing sleep apnea, COPD, and other respiratory conditions. Their focus on digital health and connected care solutions positions them at the forefront of healthcare innovation.

Company Size: ResMed is a large, established company, typically employing over 9,000 employees globally. This size indicates a well-structured organization with established processes, significant resources, and opportunities for career advancement.

Founded: ResMed was founded in 1989. With over three decades of experience, the company has a strong history of innovation and market leadership, particularly in sleep and respiratory care.

Team Structure:

• The Regulatory Affairs team likely operates as a specialized function within the broader Product Development or R&D organization. It will consist of professionals with expertise in various regulatory domains, including software, hardware, and global compliance.

• This role will report into a Regulatory Affairs Manager or Director, with potential for mentorship from senior specialists or subject matter experts.

Methodology:

• Data-Driven Regulatory Strategy: Decisions are informed by regulatory intelligence, risk assessments, and product performance data.

• Agile & Iterative Development Support: The team supports product development processes, which may include agile methodologies, requiring flexible and responsive regulatory input.

• Global Compliance Focus: Emphasizes building robust processes that ensure compliance across diverse international regulatory frameworks.

Company Website: https://www.resmed.com/

📝 Enhancement Note: ResMed's established presence in the medical device industry, coupled with its strong push into digital health, suggests a culture that balances rigorous compliance with innovation. The "Advanced Specialist" title implies an environment where deep expertise is valued, and individuals are empowered to contribute strategically.

📈 Career & Growth Analysis

Operations Career Level: This "Advanced Specialist" position represents a significant individual contributor role within the Regulatory Affairs function. It signifies a level beyond entry-level or junior specialist, requiring independent work, strategic input, and potentially mentorship of junior colleagues. It's a critical role for driving product innovation and market access in the digital health space.

Reporting Structure: The role will likely report to a manager or director within the Regulatory Affairs department. This structure provides clear lines of accountability and mentorship, while the cross-functional nature of the work ensures broad exposure to different aspects of product development.

Operations Impact: This role has a direct and substantial impact on ResMed's ability to bring innovative digital health solutions to market. Successful regulatory strategy and execution are critical for product launch timelines, market access, patient safety, and overall business growth. The ability to navigate complex regulations for SaMD and AI/ML directly influences the company's competitive edge in connected care.

Growth Opportunities:

• Specialization Advancement: Deepen expertise in specific areas like AI/ML regulatory compliance, cybersecurity for medical devices, or specific regional regulations, potentially leading to Principal or Lead Specialist roles.

• Leadership Development: Transition into management roles, leading project teams or a dedicated regulatory sub-function, or becoming a subject matter expert (SME) for critical product lines.

• Cross-Functional Mobility: Leverage regulatory expertise to move into related areas such as Product Management for regulated products, Quality Assurance leadership, or Global Compliance strategy.

• Industry Influence: Contribute to industry working groups, standards development, or regulatory policy discussions.

📝 Enhancement Note: The "Advanced Specialist" title indicates a strong focus on subject matter expertise. Growth opportunities are likely to involve deepening this expertise or moving into leadership roles that leverage this specialized knowledge. The emphasis on digital health suggests a dynamic growth path as this sector expands.

🌐 Work Environment

Office Type: While the role is designated as fully remote, ResMed maintains physical office locations. For remote employees, the "office" is a home-based environment. The company culture promotes a collaborative atmosphere, facilitated through virtual tools and occasional in-person meetings or company events for remote teams.

Office Location(s): The job posting lists "US Field Non-Sales (Remote Workforce)" and mentions "San Diego, CA, United States" as a derived location. This indicates that while the role is remote, the company is headquartered in San Diego, and there may be a preference for candidates within a certain proximity or time zone for easier collaboration, though not strictly required.

Workspace Context:

• Collaborative Remote Environment: Expect to utilize a suite of digital collaboration tools (e.g., Microsoft Teams, Slack, video conferencing) to interact with colleagues and cross-functional teams.

• Technology & Tools: Access to necessary software, regulatory databases, and company-provided hardware to perform job duties effectively from a remote location.

• Team Interaction: Regular virtual meetings, team syncs, and project-specific collaborations are standard for remote operations professionals.

Work Schedule:

• The standard 40-hour work week provides a baseline, but the remote nature often allows for flexibility in structuring the workday. This is particularly beneficial for regulatory professionals who may need to coordinate with teams in different time zones or manage periods of intense submission activity followed by more analytical work. Adherence to core business hours for critical meetings and collaboration is expected.

📝 Enhancement Note: The remote designation is key. Candidates should be comfortable and proficient in a remote work setting, demonstrating strong self-management and communication skills. The mention of San Diego suggests potential for occasional travel to headquarters for key meetings or company events, though this is not explicitly stated.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A recruiter or hiring manager will conduct an initial phone screen to assess basic qualifications, experience, and cultural fit.

• Hiring Manager Interview: A more in-depth discussion with the hiring manager focusing on regulatory experience, strategy, and specific knowledge related to SaMD and digital health.

• Cross-functional Panel Interview: Interviews with key stakeholders from R&D, Product Management, or Quality Assurance to evaluate collaboration skills and understanding of product development lifecycles.

• Case Study/Presentation: Candidates may be asked to prepare and present a case study on a relevant regulatory challenge, such as developing a regulatory strategy for a new digital health feature or assessing the impact of a regulatory change.

• Final Interview: Potentially with a senior leader (e.g., Director of Regulatory Affairs) for final assessment and offer discussion.

Portfolio Review Tips:

• Focus on Impact: Clearly articulate the business and patient impact of your regulatory contributions. Quantify results where possible (e.g., "reduced submission review time by X%", "enabled market launch in Y regions").

• Structure Your Case Studies: For any regulatory strategy or assessment examples, use a clear structure: Problem/Challenge, Your Approach/Strategy, Actions Taken, Outcome/Results, Lessons Learned.

• Highlight Digital Health Expertise: Emphasize your experience with SaMD, AI/ML, and the specific regulatory nuances involved. Showcase how you translate complex technical features into regulatory requirements and vice-versa.

• Redact Sensitive Information: Ensure all proprietary or confidential information is properly redacted from any sample documents or case studies presented.

• Demonstrate Communication Skills: Be prepared to walk through your portfolio items clearly and concisely, answering questions thoughtfully and demonstrating strong communication abilities.

Challenge Preparation:

• Anticipate Regulatory Scenarios: Be ready to discuss hypothetical scenarios related to new product submissions, change control assessments for software updates, or responses to regulatory inquiries.

• Prepare for Strategy Questions: Think about how you would approach developing a regulatory strategy for a novel digital health product with AI/ML components.

• Practice Presentation Skills: Rehearse presenting your portfolio items or case studies, focusing on clarity, conciseness, and engagement.

📝 Enhancement Note: The interview process is likely to be rigorous, reflecting the critical nature of regulatory affairs in the medical device industry. Candidates should be prepared to demonstrate both deep technical regulatory knowledge and strong strategic thinking, especially concerning digital health innovations. A well-prepared portfolio is essential for showcasing practical experience.

🛠 Tools & Technology Stack

Primary Tools:

• Regulatory Information Management (RIM) Systems: Experience with systems used for managing regulatory filings, documentation, and compliance tracking (e.g., Veeva RegulatoryOne, Greenlight Guru, MasterControl).

• Document Management Systems (DMS): Proficiency in using systems for controlled document creation, review, and approval, essential for regulatory compliance (e.g., SharePoint, Documentum).

• Project Management Software: Tools to manage project timelines, tasks, and cross-functional collaboration (e.g., Jira, Asana, Microsoft Project).

Analytics & Reporting:

• Regulatory Intelligence Databases: Access to and utilization of databases for tracking global regulatory changes and requirements (e.g., RAPS, Emergo by UL, specific country regulatory agency websites).

• Spreadsheet Software: Advanced proficiency in Microsoft Excel or Google Sheets for data analysis, tracking, and reporting of regulatory metrics.

CRM & Automation:

• Internal Collaboration Platforms: Tools like Microsoft Teams, Slack, or Zoom for communication and virtual meetings.

• Product Lifecycle Management (PLM) Systems: Familiarity with systems that manage product data throughout its lifecycle, often integrating with regulatory requirements.

📝 Enhancement Note: While specific tools aren't listed, candidates should highlight experience with common regulatory affairs software and general productivity/collaboration tools. The emphasis on SaMD and digital health suggests familiarity with tools used in software development environments (like Jira) might be beneficial.

👥 Team Culture & Values

Operations Values:

• Patient Focus: A core value driving the commitment to delivering safe and effective medical devices that improve patient outcomes.

• Innovation: Encouraging the development of novel solutions and embracing new technologies, particularly in the digital health space.

• Integrity & Compliance: Upholding the highest ethical standards and ensuring strict adherence to all applicable regulations.

• Collaboration: Fostering a team-oriented environment where cross-functional partners work together seamlessly to achieve common goals.

• Excellence: Striving for high performance in all aspects of work, from strategic planning to day-to-day execution.

Collaboration Style:

• Proactive Partnership: Engaging early and often with product development teams to integrate regulatory considerations into the design process.

• Clear Communication: Translating complex regulatory requirements into understandable guidance for diverse stakeholders.

• Feedback-Driven Improvement: Open to constructive feedback and actively participating in process improvement discussions to enhance regulatory efficiency and effectiveness.

• Knowledge Sharing: Actively sharing regulatory insights and best practices across teams to build collective understanding and capability.

📝 Enhancement Note: ResMed's culture likely emphasizes a strong ethical foundation, a drive for innovation to improve patient lives, and a collaborative approach to problem-solving. For a regulatory role, integrity and a commitment to compliance are paramount, balanced with the agility needed to support fast-paced digital health development.

⚡ Challenges & Growth Opportunities

Challenges:

• Rapidly Evolving Digital Health Regulations: Keeping pace with the dynamic and often fragmented regulatory landscape for SaMD, AI/ML, and connected health technologies globally.

• Balancing Innovation with Compliance: Supporting cutting-edge technological advancements while ensuring rigorous adherence to safety and efficacy standards.

• Global Regulatory Harmonization (or lack thereof): Navigating diverse and sometimes conflicting regulatory requirements across different international markets.

• Integration of New Technologies: Understanding and applying regulatory frameworks to emerging technologies like advanced algorithms and AI, which may not have well-established pre-existing guidance.

Learning & Development Opportunities:

• Specialized Training: Access to training programs focused on digital health, AI/ML regulations, cybersecurity for medical devices, and specific regional compliance requirements.

• Industry Engagement: Opportunities to attend key industry conferences (e.g., RAPS, AdvaMed) and participate in working groups to stay abreast of regulatory trends and network with peers.

• Mentorship Programs: Guidance from senior regulatory affairs leaders within ResMed to foster career growth and expertise development.

• Certification Support: Potential for company support for obtaining relevant professional certifications in regulatory affairs.

📝 Enhancement Note: This role is positioned at the cutting edge of medical device regulation. The primary challenges stem from the novelty and rapid evolution of digital health technologies. Growth opportunities are directly tied to developing expertise in these emerging areas.

💡 Interview Preparation

Strategy Questions:

• "Describe your process for developing a regulatory strategy for a new Software as a Medical Device (SaMD) product, considering both US FDA and EU MDR requirements." (Focus on risk-based approach, key submission components, and stakeholder alignment.)

• "How would you assess the regulatory impact of an algorithm modification in an AI/ML-enabled medical device? What steps would you take?" (Highlight assessment methodology, change control, and communication with development teams.)

Company & Culture Questions:

• "What interests you specifically about ResMed and our focus on digital health solutions?" (Research ResMed's mission, products, and recent innovations in connected care.)

• "How do you ensure effective collaboration with non-regulatory stakeholders, such as engineers and product managers, who may have different priorities?" (Emphasize communication strategies, understanding stakeholder perspectives, and finding common ground.)

Portfolio Presentation Strategy:

• Select Impactful Examples: Choose 2-3 key projects or case studies that best showcase your experience with SaMD, regulatory strategy, submission authoring, or complex change assessments.

• Structure Your Narrative: For each example, clearly outline the challenge, your role and actions, the regulatory framework involved, the outcome, and any lessons learned.

• Quantify Results: Wherever possible, use data to demonstrate the impact of your work (e.g., time saved, successful approvals, market access achieved).

• Be Prepared for Deep Dives: Anticipate detailed questions about your decision-making process, regulatory rationale, and technical understanding.

📝 Enhancement Note: Interviewers will be looking for a blend of regulatory expertise, strategic thinking, and practical problem-solving skills, particularly within the context of digital health. Candidates should be ready to articulate their experience with specific regulatory frameworks and demonstrate how they apply them to innovative technologies.

📌 Application Steps

To apply for this operations position:

• Submit your application through the ResMed careers portal link provided.

• Tailor Your Resume: Highlight specific experience with Software as a Medical Device (SaMD), AI/ML-enabled features, FDA 510(k) submissions, EU MDR, and digital health products. Use keywords from the job description to ensure ATS compatibility.

• Prepare Your Portfolio: Curate 2-3 strong examples of your work in regulatory strategy, submission contributions, or regulatory assessments, focusing on digital health products. Be ready to present these concisely and clearly.

• Research ResMed: Understand ResMed's product portfolio, especially their connected care and digital health offerings, and their company mission and values.

• Practice Interview Responses: Prepare to answer behavioral and situational questions using the STAR method, focusing on your regulatory experience, problem-solving skills, and cross-functional collaboration abilities.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.