Job ID :
Malaysia - Kuala Lumpur|Singapore - Marsiling
- Take overall responsibility of Regulatory Affairs for SDG SEA
- Ensure that SDG SEA is in compliance with required Medical Device and IVD regulations
- Be responsible to work with the divisions to complete needful registrations for existing products and new launches
- Build rapport with regulatory agencies and notified bodies as required across SEA, to perform effective and fast approvals for product registrations.
- Be the voice of SEA divisions to get all needful documentation and support from our divisional headquarters or manufacturing sites to get the registrations completed
- Create a tracking mechanism to ensure that all products we sell through our direct team are registered in the individual country. Support distributors to get the needful documents to complete their registration
- Work closely with divisional headquarters to provide regulatory guidance for new product launch and registering them in various markets.
- Be responsible for regulatory inspections
- Monitor the regulatory development and trends in the region and report impact to the organization
- Review labeling and promotional materials for regulatory compliance (when needed)
- Build rapport with regulatory authorities, RA counterparts within LT and external partners
- Post market surveillance, reporting adverse events/recalls to the Authority
Minimum Education and Experience Requirements:
- University degree in Biochemistry or related area. Master Degree highly desirable
- Minimum of 4 years Professional experience in a regulated environment. IVD or healthcare industry experience with a successful track record in regulatory affairs
- Knowledge and experience in regulatory requirement: FDA 21cfr part 820, EU CE IVDD, ISO 9001 / 13485. Experience in product local and regional regulatory submissions / registrations
Knowledge, Skills, and Abilities:
- It is a basic requirement that the job holder is able to communicate within the company and externally in an effective and authoritative manner, both in writing and verbally. A good command of written and verbal use of the English language is essential, together with the ability to think clearly and marshal ideas. Spoken communication must be clear and confident and must show evidence of good listening skills.
- The job holder must possess the highly developed interpersonal and social skills necessary to represent the Company and to be able to communicate at all levels both internally and externally. These skills must be complemented by the ability to work as a member of a team, building consensus and the co-operation of colleagues and external contacts.
- Travel requirement : 25%
- Positive attitude and be proactive and pragmatic
- Excellent presentation skill
- Good industry contacts and leadership
- Experience of working with distributors and direct team