- Ensure that company’s products comply with the applicable regulations.
- Maintain and update national and international legislation, guidelines and customer practices.
- Collect, collate and evaluate scientific data from a range of sources.
- Develop and write clear arguments and explanations for new product license as well as license renewal.
- Prepare submission of license variations and renewal approvals.
- Monitor and set timeline for license variations and renewal approvals.
- Write clear, accessible product labels and instruction leaflets.
- Involved in post-market surveillance reporting as guided by the Senior Group RA Manager.
- Advise R&D team on regulatory requirements and regulatory strategy.
- Undertake and manage regulatory inspections and technical documentation audit.
- Maintaining the technical documentation and EU declaration of conformity together with Senior Group RA Manager.
- Review company practices and provide advice on changes / improvement to the system.
- Liaise with and make presentations to regulatory authorities.
- Negotiate with regulatory authorities for marketing authorization.
- Specify storage, labelling and packaging requirements.
- Actively involved in company’s environmental initiatives.
- Ensure that target agreed for the KPI’s under the responsibility of the position are achieved.
- To ensure all other duties and projects as assigned by the superior are done.
- Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree in Scientific Discipline.
- At least 1 year of working experience in the field of medical devices and regulatory affairs on medical devices.
- Required Language: Well versed in English, Bahasa Malaysia & Mandarin.
- Analytical and problem solving skills.
- Full time position available.
- Applicants must be willing to work in Pontian, Johor.
Perks & Benefits
- Allowance (phone, transportation, etc.)
- Flexible working hours
- Regular team activities
- Medical insurance
- Open culture
Lot 2244, Batu 39 1/2, Pontian Besar, 82000 Pontian, Johor, Malaysia.
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Total 2 jobs
Business Development Executive
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