**Tasks**- We are currently looking for a Medical Auditor to perform the Audits, inspections, and trainings for clients to help ensure that our client's meet the requirements of International requirements.- This includes the following areas:- Performing Audits in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standards- Performing ISO 13485 / MDD / specific medical standards / and GMP inspections- Performing in-house and public training for clients (e.g. ISO 13485 / MDD / Specific Medical Device Standards / QSR)- Key Responsibilities:- Conduct audits on clients' medical device quality systems based on regulatory requirements for access into EU, Japan, and Canada- Assist Sales by providing technical advice to existing and prospective clients and responding to inquiries relating to medical device certification- Process clients' queries, Change Notifications, EC certificate extensions and audits effectively within acceptable time frames or when due, including quotations and contract reviews where necessary- Take charge of pre and post-audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentation and submission files and maintaining filling of paper and electronics records- Maintain authorizations for auditing and technical reviews and corresponding objective evidence- Ensure timely completion of audit/surveillance and submission of audit reports- Develop and review audit methodologies for accreditation compliance- Provide support for other departments on day-to-day planning, marketing, operations, and new product development.- Undergo relevant training, qualification, or certification process to be qualified to provide further services.- To implement and uphold medical device laws and regulations of the country- To generate, compile and prepare assessment reports and recommendations for review of certification bodies.**Qualifications**- ** Key Requirements**:- Minimum 5 years of relevant experience in the medical industry, with at least 2 years in Quality Assurance work with manufacturers of medical devices with a relevant Bachelor's degree.- Good knowledge of medical device directives, ISO 9001, and ISO 13485 standards will be an added advantage- Global Regulatory Affairs background, including MDD/IVDD is preferred- Clear and articulate presentation ability with excellent communication skills- Travelling will be required within ASEAN, largely Thailand and Malaysia, occasional travel to the USA and Europe- Willing to be relocated to ASEAN countries
