About the job:
Responsible for supporting administrative and operations aspects of Regulatory Affairs (RA) activities in Singapore and Malaysia to ensure compliance with requirements of local authority and Stryker Corporate Policy.
What you will be doing:
Update, monitor and maintain various RA databases or systems, ensuring accuracy of data and hence proper control of registered product.
Assist in providing license information and relevant supporting document as and when requested by the business.
Assist in performing license information checking when requested.
Assist in tasks related to payment/invoice processing.
Supporting change notification assessment and submissions, pre-market submissions, special access submission related activities as and where required.
Supporting post-market activities and ensure timely reporting to authority where required.
Maintain good communication and collaboration with internal and external customer (commercial, distributor, manufacturing divisions, authority).
Any other tasks relevant to RA.
Who are we looking for:
Diploma / Bachelor degree in Engineering, Science, or related degree; or MS in Regulatory Science.
Fresh graduates are welcome to apply.
Proficiency in using MS Excel and other MS Office applications.
Good communication and co-ordination skills are required to liaise with internal and external colleagues and service providers.
Good planning and time management skills.
Team player, with excellent administration skills.
Regulation knowledge on medical devices is a plus.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.