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- ...-level debugging. Test Development & Deployment Oversee the design, development, and implementation of test systems (FCT, ICT, MDA), ensuring timely delivery for NPI and production ramp. Test Strategy & Performance Define test strategies, coverage, and ensure...
- ...regulatory strategies aligned with business goals for Malaysia and Brunei. Serve as the primary liaison with health authorities (MOH, DCA, MDA, PHAMA, enforcement bodies). Lead regulatory planning for new product launches, lifecycle management, biosimilar portfolios, and...
MYR 800 per month
...About Us: We are a licensed face mask manufacturer with our own factory in Selangor. All our products are certified with: -✅ MDA License -✅ ISO 13485 Certification -✅ 99% BFE/PFE Filtration Efficiency -✅ ASTM Level 3 and EN14683:2019 Type IIR...- ...in communication, appearance, and customer engagement at all times. Ensure full compliance with company policies, procedures, and MDA marketing guidelines. Maintain accurate and timely records of sales activities, customer interactions, and field performance reports...
- ...Represent the Company in pharmacy‑ and regulatory‑related activities organized by authorities or professional bodies (e.g. NPRA, MDA). Provide support for clinical and product training to sales teams and targeted healthcare professionals (HCPs). Manage medical...
- ...IT implementation projects in regulated environments. ~ Familiarity with medical device regulations in Malaysia and globally (e.g., MDA, FDA, EU MDR). ~ Experience in documentation, change control, and audit support. ~ Excellent communication skills for stakeholder...
- ...FDA 21 CFR Part 820. . Basic understanding of regulatory requirements for medical devices in Southeast Asia countries (e.g., HSA, MDA, TFDA, etc.) is a plus. . Experience in post‑market quality activities such as adverse event reporting, vigilance, or FSCA coordination...
- ...Responsibilities Develop Power Apps (Canvas & MDA) apps for simple to moderate project requirement (L1 & L2). Develop Power Automate for simple to moderate project requirement (L1 & L2). Responsible for interacting with users on a day-to-day basis, to understand...
- ...(Country Manager, Regional Director, or equivalent) 2Proven success in growing IVD sales 3Deep understanding of IVD regulations (MDA and related other local compliance) 4Strong network with labs, hospitals, and distributors in Malaysia 2Preferred: 1Work experience...
- ...Technical skills: Knowledge in one or more programming languages, tools and technologies, including JavaScript, C#, HTML, CSS, Canvas, MDA, and Power Automate, web resource, Dataflow, and Dataverse. Can write code, debug issues, and understand libraries and frameworks...
- ...strategy and positioning. Compliance & Governance Ensure all communications comply with: Malaysian Medical Device Authority (MDA) guidelines. Siemens Healthineers branding, legal, and regulatory standards. Healthcare industry codes of conduct. ~ Manage...
- ...and FSSC 22000 standards. Global Standards: Ensure 100% compliance with local and international bodies including FDA, USDA, EU, MDA, and MOH. Audit Leadership: Act as the Lead Liaison for all internal, third-party, and customer audits. You will be responsible for...
- ...The role also involves building and maintaining strong relationships with government agencies (e.g., Customs, MOH, DOSH, MOFA, DVS, MDA, MAQIS,etc.), industry associations, NGOs, and internal stakeholders such as Quality, Customer Service, Sales & Marketing, Warehouse,...
