Key Job Purpose:
Maintaining in regulatory compliance in each country under territory in Asia Pacific region through:
- Timely renewal of any regulatory licenses / approvals as required, as well as to fulfill any regulation changes
- Preparation of technical documents for regulatory submission for any new products in country
- Assisting affiliate companies and their regulatory operations
Assisting collaborative works with headquarter, legal manufacture in Japan, through:
- Timely preparation of technical documents for complying any regulation changes, new regulations, and new product launches in Asia Pacific region
- Information sharing regional as well as country specific regulatory requirements in order headquarters to prepare necessary documents surely and timely
Assisting to make continual improvements in regulatory operational processes in the company as well as in affiliates, in order to achieve also compliance with global level regulations
Job Responsibilities:
Product Registration:
Assist SAP, Asia Pacific affiliate and distributors for the following six activities.
- To prepare & submit product registration documentation & other relevant licences’ application that lead to timely approval of new or changed product registration in Asia Pacific
- To acquire data/information from manufacturers, drafting/assisting in preparation of initial dossier for submission
- To maintain product registration record and product registration database to ensure proper documentation and record filing for all affiliates and business partner countries
- To maintain the knowledge and awareness of current applicable regulations and standards for all affiliates and business partner countries
- To support business partners in new product registration, renewals, and amendments
- To support Sales & Marketing and SCM in all regulatory related areas
Collaborative works with headquarter (which requires fluent Japanese speaking skills)
- To assist timely preparation of technical documents and to achieve proper regulatory submission for any new products registration and the approval
- To provide / share any important regulation changes in country, updates from regional industry associations, advisory & knowledge in order headquarter to prepare necessary documents met regional requirements in timely manner
- To be assigned for special project led by corporate level as required (e.g. recent India new factory project, manufacturing address change)
To propose and assisting to execute making improvements and/or effective ways in regulatory operational processes in company in order to achieve complying with all global level regulations, through:
- To continue learning regulations and these requirements such as IVD-R, MDSAP, APAC Med
- To launch and leverage Regulatory Information Management System (RIMS) for better progress management of any special projects, regulatory submissions, and regulatory licenses in each country
- To provide supports to affiliate companies in order to enhance regulatory capabilities as well as operational processes, also for better collaborative works
Any other special projects and duties as assigned
Job Requirements:
- At least a Diploma in Medical Science or its equivalent.
- At least 5 years experience in regulatory affairs including regulation research, technical documents creation and regulatory submission.
- Medical Device Act & other medical device related regulations in Asia Pacific countries
- Fluent Japanese and English Speaker
- Knowledge of major IVD regulations/standards, at least IVD-R, ISO13485, MDSAP
- Basic computer knowledge & application, e.g. Microsoft Office, Power PDF, etc
- Knowledge on the regulation of other than In-vitro medical device types, e.g., software, general medical device, POC will be an advantage
