Our Client:

Our client is one of the top leading healthcare manufacturing companies with its Headquarters in Japan.

Their Singapore office is looking for an Executive - Regulatory Affairs.

The Responsibilities:

The Executive - Regulatory Affairs coordinates the registration/market access process (regulatory affairs) so that product launch schedules are met, customer satisfaction is achieved including compliance with the applicable regulatory requirements, within the scope of OHS-G's quality management systems and policy.

Cover areas: Singapore, Malaysia, Vietnam

* Coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to allow "as early as possible" product registration
* Provides advice to internal and external teams in interpreting relevant guidance documents and standards
* Analyse and make recommendations regarding complaints received and whether they are reportable within the designated areas; participate in post-market surveillance activities as necessary
* Contact with local authorities and organizations for both regulatory problems solving and obtain update information on current and developing regulations
* Remain up to date on regulations and communicate any key changes to stakeholders in the broader organization. Provide training as necessary and assist with the development of the respective countries' Regulatory Affairs infrastructure to facilitate greater speed to market
* Participate in and/or support various teams and projects to define regulatory requirements for the designated sales areas, including product classification and type of regulatory submission required

The Requirements:

* Min. Diploma and/or experience in medical device or related field
* 2-4 years of experience in product, business processes / procedures, regulatory frameworks, and requirements for Medical Devices
* Good knowledge of Microsoft Office (Word, Excel)

Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.