Regulatory Affairs Specialist

Based at our Singapore headquarters, the Regulatory Affairs Specialist will support the development and execution of regulatory strategies for UroMedtech products across international markets.

The role will be responsible for preparing and coordinating medical device registration submissions, maintaining regulatory documentation, responding to authority queries, managing regulatory activities with distributors and local representatives, and supporting post-market regulatory compliance.

The successful candidate will play an important role in enabling UroMedtech's international expansion by ensuring that regulatory pathways are planned early, submissions are executed efficiently, and product registrations remain compliant throughout the product lifecycle.

Key Responsibilities

International Product Registration

• Support and coordinate medical-device registrations across UroMedtech's priority international markets.
• Prepare, compile, review and maintain regulatory submission dossiers in accordance with applicable country requirements.
• Coordinate registration activities with local distributors, authorized representatives, regulatory consultants and other in-country partners.
• Track submission status, authority queries, approvals, licence validity and renewal requirements.
• Prepare responses to regulatory authority questions and requests for additional information in collaboration with relevant internal teams.
• Maintain clear registration timelines and proactively identify potential regulatory delays or risks.
• Support regulatory activities for new products, new indications, product modifications and market expansion.

Regulatory Strategy & Market Access Planning

• Research and assess regulatory pathways and classification requirements for new international markets.
• Support development of country-specific regulatory strategies, timelines, documentation requirements and registration plans.
• Identify regulatory dependencies that may affect product launch or commercial timelines.
• Provide regulatory input to Commercial and Management teams during market-entry planning.

Technical Documentation & Submission Dossiers

• Prepare and maintain regulatory technical documentation and submission dossiers in accordance with applicable requirements.
• Support preparation and maintenance of device descriptions and intended use, product specifications, Essential Principles / General Safety and Performance Requirements, documentation relating to risk management, verification and validation, software, clinical evaluation and clinical evidence, applicable biocompatibility and electrical safety, labelling, Instructions for Use, packaging, and Post-Market Surveillance.
• Ensure regulatory documents are accurate, consistent, traceable and appropriately controlled.
• Coordinate with R&D, Engineering, Clinical and QA teams to obtain required technical evidence and supporting documentation.

Product Change & Lifecycle Management

• Assess regulatory implications of product, software, manufacturing, labelling and supplier changes.
• Support regulatory change assessments and determine whether notifications, variations or new submissions are required in relevant markets.
• Maintain accurate records of country-specific approved product configurations and regulatory commitments.
• Coordinate regulatory activities related to product updates and software releases.
• Support licence renewals and ongoing maintenance of international registrations.

Regulatory Partner & Distributor Management

• Serve as a key regulatory contact for international distributors and local regulatory representatives.
• Provide distributors with appropriate regulatory documentation and guidance for local registrations.
• Review regulatory materials prepared by distributors or external consultants for accuracy and consistency.
• Establish clear responsibilities, timelines and follow-up actions for registration projects.
• Maintain organized records of regulatory correspondence, submissions, approvals and commitments by country.

Quality & Post-Market Regulatory Support

• Work closely with QA to support compliance with the company's Quality Management System and applicable medical-device regulations.
• Support regulatory reporting requirements related to complaints, adverse events, field safety corrective actions and other post-market activities when required.
• Support regulatory inspections, audits and authority requests when required.
• Ensure regulatory commitments made during product registration are communicated internally and fulfilled.

Cross-Functional Collaboration

• Collaborate and work with Product, R&D, Clinical, Commercial, Operations and Manufacturing teams regarding regulatory requirements, documentation, submissions, and timelines.
• Participate in cross-functional product development and product-change meetings where regulatory input is required.

Regulatory Intelligence

• Monitor relevant regulatory developments in international medical-device markets.
• Maintain current knowledge of applicable standards, guidance documents and regulatory requirements.
• Assess emerging regulatory requirements relevant to medical robotics, software, AI-enabled medical devices and image-guided technologies.
• Communicate significant regulatory changes and their potential business impact to relevant internal stakeholders.

Qualifications & Experience

• Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Medical Science, Engineering or a related discipline.
• Approximately 3–6 years of Regulatory Affairs experience within the medical-device industry.
• Hands-on experience preparing or supporting medical-device registration submissions.
• Working knowledge of medical-device technical documentation and Quality Management Systems.
• Familiarity with ISO 13485, ISO 14971 and applicable medical-device regulatory frameworks.
• Experience coordinating regulatory submissions with internal stakeholders and external partners.

Preferred Experience

• Experience with regulatory requirements and submissions in multiple international markets, particularly EU/CE, US/FDA and Asia-Pacific region (Singapore, ASEAN).
• Experience with Australia TGA, CE and FDA international regulatory pathways would be advantageous.
• Experience with Class II / Class III or equivalent moderate-to-high-risk medical devices.
• Experience with software-containing medical devices, medical robotics, ultrasound, imaging or AI-enabled medical technology.
• Familiarity with IEC 60601, IEC 62304, IEC 62366 and other relevant medical-device standards.
  Experience working with international distributors, authorized representatives and regulatory consultants.
• Experience supporting product changes, software updates and lifecycle regulatory activities.

Skills

FDA, Regulatory Compliance, Quality Assurance, Regulatory Affairs, ISO, Regulatory Strategy, TGA, Biomedical Engineering, Medical Devices, Regulatory Support, Medical Device Regulations, Regulatory Processes, Stakeholder Management, Product Lifecycle, Regulatory Submissions