Rosyahirah Roseli

Regulatory Affairs Executive assigned in QA department with 3 years experience in Medical Device and FMCG industries. Familiar with MDA, NPRA, EU MDR 2017/745 and other international regulations. Trained and certified in ISO 13485 and ISO 45001. Passionate to learn and gain new knowledge.

• Negotiated with regulatory authorities (MDA, LNE, US FDA, and etc.) for marketing authorities. 
• Maintained and updated national and international legislation, guidelines and costumer practices such as ISO, ASTM, EU MDR. 
• Collected and evaluated scientific data from a range of source. 
• Develop and write clear arguments and explanations for new product license as well as license renewal. 
• Prepared submission of license variations and renewal approvals. 
• Ensured the artwork provided by customer fulfill the regulatory requirement of ISO 4074, EN ISO 4074, ASTM D3492, NF062, WHO 2010 and etc. 
• Involved in post-market surveillance reporting yearly. 
• Undertake and manager regulatory inspections and technical documentation audit. 
• Ensured that target agreed for the KPI's under the responsibility of the position are achieved. 
• Ensured all other duties and projects as assigned by the superior are done. 
• Prepared for medical device reporting for reportable incident. 
• Performed gap analysis for new/revised regulation.
• Prepared all documentation for product registration and product renewal with NPRA as well as reviewed for artwork labelling. 
• Ensured the products meet the regulatory requirements of Brunei for product re-export.

Bachelor Degree of Science (Physics) from Universiti Teknologi Malaysia (UTM) with CGPA 3.44.