
Global Regulatory Affairs Professional
2 days ago
We are seeking a highly skilled Global Regulatory Affairs Specialist to join our team. This role will be responsible for efficiently obtaining and maintaining product registrations in APAC countries, working closely with distributors, consultants, regulators, and HOYA affiliates.
- This position requires participation in projects, providing regulatory strategy and timelines where required.
- It involves ensuring regulatory submissions are executed on-time and in a cost-effective manner.
- The incumbent must maintain regulatory licenses and on-time renewals to avoid supply disruption.
A key aspect of this role is adequate and effective relationship management, ensuring contractual agreements are in place (where applicable) with Third Party License Holders, Regulatory Agencies, Consultants, stakeholders to meet the regulatory goals.
- This position also requires ensuring regulatory activities performed are in compliance with both internal and external regulations/requirements.
- Supporting the business in obtaining timely regulatory documentation required to import/export and/or to obtain market access/reimbursement/tender approval.
In addition, this role involves representing as Global RA lead relating to change controls initiatives/activities, providing clear communication on the proposed changes and working closely with SMEs, regional RAs to obtaining timely and accurate global RA impact assessment and formulate the global RA strategy with minimal business impact.
Requirements:- Minimum 5 years of APAC Regulatory Affairs experience in Medical Device Industry, especially in South East Asia, Korea, in a multi-cultural environment.
- Experience in Class 3/Class C, D general devices preferred.
This role offers an excellent opportunity to work with a dynamic team and contribute to the success of our organization. If you have the skills and qualifications we are looking for, please submit your application for consideration.
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