Regulatory Affairs Manager ASEAN/NA, Global Healthcare Firm
|Job Title:||Regulatory Affairs Manager ASEAN/NA, Global Healthcare Firm|
|Contact Name:||Jolene Lee|
|Job Published:||April 09, 2019 13:11|
In this position, you will provide leadership oversight and management for all matters of regulatory affairs for whole product portfolio and business operations in ASEAN and North Asia. Responsibilities include obtaining pre-market clearances, registrations and renewals (including Local Authorization Holder (LAH) in Malaysia), and local registration license for repair/service centers if available. You will meet Global Business Units post-market obligations (such as adverse event reporting, fields action and recall, and CAPA management) and provide any necessary regulatory support to commercial business operations in ASEAN and North Asia.
Ideally, you have a minimum 8 years in the medical device area with direct experience and track record in interactions with the local regulatory agencies. Preferably have experience in manufacturing, quality assurance, and/or engineering role.
You can effectively communicate regulatory requirements to stakeholders with ability to plan and prioritize projects based on importance to business plan and resource availability. Possess effective project management skills and strong knowledge of quality management systems, e.g. FDA 21 CFR and QS13485. Strong knowledge and experience with other countries' regulatory requirements, e.g. US 510(k) submission, EU MDD 93/42/EEC preferred.
Singapore Employment Agency Licence No: 16S8069
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