Regional Regulatory Affairs Specialist
Medical Devices Industry
Training is provided
About Our Client
A medical device company which is the headquartered in Singapore. They have R&D facilities in Japan and Singapore; a manufacturing plant in Singapore; sales and marketing offices in Europe, Japan, Singapore, and U.S.
As Regional Regulatory Affairs Specialist your responsibilities will include but not limited to:
- Compile and maintain registration files for APAC regions under the direction of the supervisor.
- Registration of new products and maintenance of registered product license in countries assigned by the supervisor.
- Execute administrative tasks related to the product registration process.
- Support the business in obtaining on-time documents required to import/export products or to obtain reimbursement
- Communicate with consultants, agents, distributors or other stakeholders in relation to registrations in process.
- Coordinate labelling change control activities with labelling team at the manufacturing site.
- Accountable for adverse event reporting review for complaints, AE and FSCA reporting to authority.
- Other activities as needed assigned by the supervisor in support of regulatory processes and/or registration.
The Successful Applicant
The ideal Regional Regulatory Affairs Specialist that we are looking for should have:
- Diploma or BSc in a related filed - science, engineering, quality, clinical studies
- Experience in Regulatory Affairs in Medical Device/Pharmaceutical industry in Singapore, Southeast Asia or APAC,
- Experience with handling regulatory files and submission processes
What's on Offer
- Continuous development and career advancement opportunities within the organisation.