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Urgent! Specialist, Regulatory Affairs Job Opening In Singapore, Singapore – Now Hiring Resmed
Position
Specialist, Regulatory Product Strategy & Delivery – Singapore (Regulatory Affairs)
Overview
Regulatory Affairs at ResMed is central to ensuring timely and compliant access to global markets.
The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer, supporting New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects to enable global submission readiness, risk assessments, and regional collaboration.
This role contributes directly to the successful delivery of regulatory strategy, submission documentation, and change management for Singapore-manufactured devices and accessories.
You will represent Regulatory Affairs on cross-functional teams and collaborate with global RA colleagues to ensure alignment, accuracy, and traceability across submissions and product lifecycle updates.
Key Responsibilities
Regulatory Strategy & Execution: Support regulatory strategy development and documentation for NPI and PLE projects led by the Singapore RPSD team.
Participate in the preparation, review, and submission of global regulatory filings including 510(k), CE MDR, TGA, Health Canada, and regional registrations.
Contribute to authoring submission content such as labeling justifications, equivalence arguments, standards declarations, and technical summaries.
Product Change Support: Evaluate the regulatory impact of product and design changes via DCA/CPA frameworks, contributing to global significance assessments and risk mitigation actions.
Review and update technical file documentation, declarations, and certificates in collaboration with the Regulatory Foundations team.
Track submission timelines and deliverables using Jira and other RA platforms.
Cross-Functional Collaboration: Represent Regulatory Affairs in cross-functional project teams involving engineering, clinical, quality, labeling, and supply chain.
Participate in design reviews, change assessments, and internal risk forums as the RA contributor for Singapore-based products.
Collaborate with Regional RA and global RPSD counterparts to ensure harmonization of documentation and submission approaches.
Regulatory Systems & Process Improvement: Maintain accurate regulatory records and document control through RIMSYS, Confluence, and SharePoint tools.
Support continuous improvement activities by contributing to template updates, process harmonization, and RA onboarding content.
Assist in audit readiness activities and postmarket traceability tasks as needed.
Other duties as required to support RA and RPSD objectives.
Required Qualifications & Experience
Bachelor’s degree in engineering, life sciences, health policy, or a related field.
3+ years of experience in Regulatory Affairs or a compliance-related role within a regulated industry (preferably medical devices).
Familiarity with product development under design control and regulatory frameworks (e.g., ISO 13485, ISO 14971, 21 CFR 820).
Strong communication, organization, and document review skills.
Ability to manage multiple priorities, meet deadlines, and operate effectively in a cross-functional team environment.
Preferred
Experience preparing or contributing to global regulatory submissions (e.g., FDA 510(k), EU MDR, TGA).
Understanding of Singapore-specific regulatory frameworks and product license processes.
Familiarity with submission and documentation tools such as Jira, RIMSYS, and Confluence.
Experience supporting Class II or III medical devices in respiratory or digital health fields.
Who You Are
You are a regulatory problem-solver and proactive collaborator.
You bring technical curiosity and process discipline to your work, with a sharp eye for detail and a strong sense of responsibility for quality.
Whether it’s preparing documentation, clarifying regulatory pathways, or contributing to design decisions—you show up with clarity, consistency, and a drive to improve.
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.
We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Software Development, IT Services and IT Consulting, and Medical Equipment Manufacturing
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Unlock Your Specialist Regulatory Potential: Insight & Career Growth Guide
Real-time Specialist Regulatory Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Specialist Regulatory in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 15252 jobs in Singapore and 14260 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in Specialist Regulatory roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Resmed is currently hiring and seeking a Specialist, Regulatory Affairs to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Resmed adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Specialist, Regulatory Affairs Jobs Singapore varies, but the pay scale is rated "Standard" in Singapore. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Specialist, Regulatory Affairs typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Specialist, Regulatory Affairs interview at Resmed, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Resmed's products or services and be prepared to discuss how you can contribute to their success.
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