JOB SUMMARY
Regulatory Affairs Executive assist in obtaining and maintaining government approval for IVD medical devices. They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Regulatory affairs Executive act as a link between companies and regulatory authorities, ensuring that products are circulated in compliance with appropriate legislation.
JOB DESCRIPTION
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Plan, manage & execute current projects: IVDR (gap closure, simplicity), biotin, AMS, cobas pure in collaboration with regional & global RA according to organization plan.
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Prepare registration dossiers according to regulatory requirements and relevant government regulations for changed in-vitro diagnostic products (IVDR)
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Plan, manage & execute new registration projects as assigned by RA manager. Effectively manage multiple project schedules & priorities.
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Prepare registration dossiers according to regulatory requirements and relevant government regulations for new launched and existing in-vitro diagnostic products
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Follow products update and submit change/ amendment dossier for registered products
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Register products’ promotional material/symposium for marketing activities
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Ensure products’ license are compliant with regulatory requirements with the necessary supporting document
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Ensure re-dressing, sub-labeling, storage and packaging requirements are compliant with Global recommendation
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Ensure the translation of all product inserts for uploading to Global e-library and for local distribution as request from business
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Organization of certificates (free sales cert and etc.) and registration product dossier
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Provide administrative support to the RA team such as organizing and maintaining RA documentation in Registration Database
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Coordinate with local BUs to prepare document that fulfil importing countries' requirement
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Provide administrative support to sale team such as copy, certify of copy, notary public for RA documentation for tender
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Liaise and work closely with the related authorities such as Medical Equipment and Construction Department (MOH)
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Monitoring changes of regulations for product registration and importation requirements and providing suggestions and implement effective ways to manage the changes
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Other duties may be assigned by the management
Liaises With
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Global RA to manage product and application related matters, technical support, updates and enquiries.
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Regulatory affairs department of Roche affiliates
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Relevant Internal Team members including Sales, Marketing, Finance, Logistics, Service, Application and other departments/areas as required
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Internal logistics team for product registration and importation related matters
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Vietnam Ministry of Health (DMEC)
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Customs
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Trade Ministry
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Notarization offices
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Suppliers: DKSH, Translation agencies, …
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External consultant
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Industry Association (Eurocham…)
Career development for this position:
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This position will give you the opportunities to learn and the business and the cutting edge practices of leading MNC company with experiences to apply them for local business development.
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Roche can provide the wide variety of career development opportunities both domestically and internationally.
JOB REQUIREMENTS
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Bachelor Degree in Health/Science/Medical Technology disciplines
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Experience in regulatory affairs at MNCs environments
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Clinical laboratory experience will be added advantage
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Multi-national companies experience is preferred
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Proficient in both English and Vietnamese (spoken & written)
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Personal Computer Skills (Microsoft Office Application)
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Effective Communication Skill
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Good Interpersonal Skill
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Creative Problem Solving Skill
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Customer Handling Skill
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Time Management Skill
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Ability to work independently and as team player
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Self-initiative and Proactive
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Presentation and Training Skill
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Project Management Skill
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Team Management Skill
To apply for the job, please email your CV and portfolio in English to mai_anh.ha@roche.com