Specialist, Regulatory Affairs

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
#J-18808-Ljbffr