Singapore
Experienced Regulatory Affairs and Quality Assurance personnel across various industry.
Strategic Key Responsibilities Global Regulatory Architecture: Design comprehensive regulatory pathways for new product submissions, aligning global market entry requirements (HSA, FDA, CE, UKCA) with business development goals. Oversee the strategic integrity of technical files, ensuring that the regulatory "logic" of submissions is robust and defensible. Governance & Management Systems: Architect and lead the integration of ISO 13485 and ISO 27001, creating a unified Quality and Information Security Management System (IMS) that supports both hardware and digital health requirements. Set the strategy for data protection and cybersecurity frameworks, ensuring the organization meets global standards like GDPR, HIPAA, and SOC II without stifling innovation. Risk Management & Compliance Oversight: Establish high-level Quality and Security objectives; lead quarterly management reviews to drive performance improvements across functional teams. Direct the internal/external audit strategy, acting as the lead liaison for Regulatory Bodies and Notified Bodies during critical inspections or high-stakes certifications. Consultancy & Mentorship: Provide expert guidance to management and cross-functional consultants on complex regulatory variations and post-market surveillance strategies. Empower functional teams to execute documentation by providing the "Golden Thread" of compliance that must be followed.
- Develop regulatory strategies for product submissions with consultants, business development and management - Manage preparation of submissions for products, variations and maintenance of existing licenses, reviewing of technical files to ensure the alignment of the requirements -Develop, implement monitor an maintain all certifications (eg. ISO 13485, MDSAP, FDA, CE, UKCA, HSA) and respective national regulatory body clearances - Develop and manage pre-market regulatory clearances and post-market regulatory activities Act as point of contact to all regulatory bodies - Develop, Implement and maintain the integrated Management system of ISO 13485:2016 and ISO 27001:2022 - Develop, implement and maintain cyber security, information security and data protection frameworks (HIPAA, GDPR, SOCII) - Monitors key quality and information security objectives and drive improvements with functional teams - Manage and execute internal and external quality audit programs
Strategic Integration: Leading the design of integrated management systems that transform regulatory compliance from a hurdle into a driver of business velocity. Engineering-Led Precision: Applying a technical, problem-solving mindset—rooted in an engineering background—to bridge the gap between complex technical execution and rigorous quality standards. Cross-Industry Expertise: Leveraging years of international experience across MedTech, Oil & Gas, and Cybersecurity to navigate diverse regulatory landscapes. Lean Compliance Frameworks: Designing cost-effective, high-performance systems aligned with ISO 13485, ISO 27001, and ISO 9001 that eliminate operational redundancy. Global Market Access: Providing specialized strategic guidance for navigating compliance requirements, accelerating speed-to-market for complex products. Quality-First Culture: Advocating for a culture where quality is embedded into the business DNA to ensure long-term scalability and competitive advantage.
1. Quality Management Systems - Develops and maintains the Quality Management Systems in accordance to ISO 9001: 2015 and Ex Approval (ISO 80079-34:2018) requirements - Conducts and arranges for audits (Internal and External) - Maintains and trains Corrective and Preventive systems - Analyses measures to improve quality systems 2. Product Approvals (Process Measurement Equipment) - Obtains and maintains Hazardous Location Product Approvals required; Ex Approvals: CE, IECEx, ATEX, UKCA National Approvals: CSA, FM, InMETRO Portia, UL, CCC, NEPSI, KTL, CML, TS etc ShipBoard Approvals: ABS, BV, DNV, LR, KR - Assists "Authorized Person" to liaise with various product approval agencies and provide effective means to coordinate certification control procedures - Conducts training to necessary personnel on Product Approvals and Hazardous Location equipment requirements 3. Digital Transformation - Leading projects to digitalize current systems to increase efficiency and analytics using Power BI within the Quality Management System in monitoring and measuring of the metrices
Responsibilities: 1. Material Review Board (MRB) - Leads a team from various job junctions to handle and coordinate quality issues regarding external vendors - Coordinate and quote any necessary rework operations with the respective departments within the facility - Conduct statistical studies for vendor related non-conformance using Statistical Process Controls and other Quality Improvement Process Tools - Drives continuous improvement projects to reduce recurring quality issues and keeping processes lean 2. Service Job Coordinator - Coordinates service jobs arising from customers' field locations, from initial request, quotations, lead time enquiries to the actual assemblies arriving at the facility for redress/repairs/investigations - Leads any investigation to determine root cause, containment and corrective action plans for equipment being returned by field locations due to quality issues 3. Internal Auditor / Regulatory Compliance - Facilitates regulatory standards integration into the company's processes -Conducts annual Quality Management System Internal Audit and monthly process audits to ensure that the procedures and processes are constantly kept up to date with the latest API/ISO requirements API: 11D1. 14A, 14L, 19AC, 19V - Facilitates customer visits and regulatory audits
1. Customization of sales order products to the needs of the customers while ensuring the safe functionality of the products when they are used down hole in the completion string. - Mechanical tri-axial loading analysis of completion tools - Assembly tolerance stack up checks with the aid of Solidworks 3D CAD software - General understanding of GD & T applications - Familiar with API 5CT requirements and various validation standards Range of products include Completions & Intervention tools as well as some prior knowledge to other products such as Sub Surface Flow Control, Packer accessories and Sand Control accessories. 2. Constant rotation to the manufacturing shop-floor as Duty Engineer to provide support for the business unit - Disposes Q-notes in the SAP system for non-conformance raised by Machining, Assembly & Test and Vendors - Construct feasible rework solutions to minimise scrap - Addresses and raises Engineering Changes Notices to the Technology team to ensure constant improvement on the products in terms of manufacturing feasibility and cost savings Range of products include Completion & Intervention products, Sub Surface Products, Sand Control and Packer accessories.
-Computed daily production process capability using Statistical Process Control tool, Minitab -Consolidated the various cutting tools used by the production plant into a document with the specifications for easy monitoring of individual tool usage -Improved the inspection time required for a particular product -Organised Family Day for staff of the entire production plant in Suzhou