Responsibilities -Assist Director with law confirmity of our product to EU Medical Device Directive MDD and EU Medical Device Registration MDRInterpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and proceduresCommunicate with regulatory authorities regarding pre-submission strategies potential regulatory pathways compliance test requirements or clarification and follow up of submissions under reviewPrepare documents submission for product registration with competent authorities around the worldMonitor product registration status and ensure validity of registrationsMaintain awareness of new legislation policies and guidelines impacting the assigned product port folioCreating and Maintenance of Product Technical Files and Company QA Manuals in-line with ISO and GDPMD requirements and Local and International Medical Device RegulationsRegistering and Maintaining Medical Devices registrations certificates for product sales and marketing according to Local and International regulationsContinuous review and improvement of processes with the Malaysia Regulatory Affairs department for submissionTimely compile of documents for license renewal registration and updateCompile and maintain systematic filling of product registration dossierRequirements -Candidate must possess at least STPM Cetificate Diploma in any disciplineAt least 3 years of working experience is required in the Medical Manufacturing fieldPreferably those specializing in regulatory affairs with FDA qualification or equivalentGood interpersonal and communciation skillsExperience with ISO 13485 and GDPMD CE and regularity affairs would be an added advantageA good command of spoken and written in English and Bahasa MalaysiaAttention to details and being able to follow instructionsAble to work under pressure and with minimum supervisionAble to commence work in short period
Type : Company job
Role : Non-Executive
Industry : Healthcare/Medical
Salary : Not Disclosed
Manufacturers of Medical Grade Plastic Circuits & Components
Mediplas Respiratory Products Sdn Bhd designs and manufactures a diverse range of plastic respiratory components and equipment covering both Adult and Neonatal segments of the Healthcare industry. These products are utilised in the Anaesthesia, Infant Care, Emergency & Accident, CSSD, ICU and Respiratory Care sections of hospitals throughout the world.
Mediplas offices are located in Kuala Lumpur, Malaysia and Victoria, Australia. Mediplas handles both local sales and exports to countries around the globe.
Mediplas are dedicated to supplying high quality components tailored to individual customer requirements.
Mediplas Respiratory Products Sdn Bhd
International Office & Manufacturing Facility:
No. 7 Jalan KIP 3, Taman Perindustrian KIP,
52200 Kuala Lumpur Malaysia
Phone: +60 3 6272 7625
Fax: +60 3 6273 6452