Specialist, Regulatory Affairs

ResMed (Malaysia) Sdn Bhd (MY); Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical device company in Singapore seeks a Specialist in Regulatory Product Strategy & Delivery. You will manage regulatory submissions, maintain documentation, and collaborate across teams to ensure compliance for Singapore-manufactured medical devices. Ideal candidates have a degree in life sciences or engineering and experience in Regulatory Affairs. Join us to shape the future of health technology through innovative solutions.

Benefits

Innovative work environment

Diverse and inclusive culture

Career development opportunities

Qualifications

• 3+ years of experience in Regulatory Affairs or compliance-related role.
• Familiarity with design control and regulatory frameworks.
• Strong organizational and communication skills.

Responsibilities

• Support regulatory strategy for New Product Introduction and Product Lifecycle Engineering.
• Prepare global regulatory filings including 510(k) and CE MDR.
• Represent Regulatory Affairs in cross-functional project teams.

Skills

Regulatory strategy development

Documentation review

Cross-functional collaboration

Risk assessment

Education

Bachelor’s degree in engineering or life sciences

Tools

Jira

Confluence

RIMSYS

Job description

About ResMed

At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.

Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.

Team Overview

Regulatory Product Strategy & Delivery (RPSD) (Singapore).

The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer. The team supports New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects, enabling global submission readiness, risk assessments, and regional collaboration.

As an individual contributor in this team, the Specialist, Regulatory Product Strategy & Delivery – Singapore will partner with cross-functional stakeholders to ensure design, documentation, and change activities meet regulatory expectations across all key markets (e.g., US, EU, APAC, LATAM)

Position Summary

As a Specialist, Regulatory Product Strategy & Delivery – Singapore, you will contribute directly to the successful delivery of regulatory strategy, submission documentation, and change management activities 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. This is a critical role in ensuring regulatory quality, efficiency, and global market continuity.

Key Responsibilities

1. 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 of submission content such as labelling justifications, equivalence arguments, standards declarations, and technical summaries.

2. 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.

3. Cross-Functional Collaboration

   • Represent Regulatory Affairs in cross-functional project teams involving engineering, clinical, quality, labelling, 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.

4. 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.

5. Other Duties and Requirements

   • Perform additional responsibilities as required to support RA and RPSD objectives.

   • Contribute to process improvements and special projects across Regulatory Affairs.

   • Support inspections, audits, and team collaboration activities.

Qualifications & Experience

Required

• 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. 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!