Key Responsibilities
- To oversee the regulatory approval and product registration for medical devices and cosmetics for Malaysia office with the support of different business units.
- Liaise with the Malaysia regulatory authority as well as overseas partners pertaining to regulatory affairs, including product registrations, variations to existing products and license renewals.
- Advise the local business divisions on regulatory and guideline requirements pertaining to their respective products.
- Initiate and provide new products registration and license renewal progress updates on regular basis.
- Provide guidance and direction to relevant parties on local regulatory requirements for product label change, manufacturing change, facility change, product line extension, shelf life and changes to technical specification of devices.
- Support and maintain compliance to the quality standards and certifications of the local office.
- Manage and maintain product complaint and ensure customer complaint reports are handled according to the company standard procedures.
- Coordinate product recalls as/ if necessary
- Up-to-date and subject matter expert on all local regulatory requirements
Key Requirements
- University Degree or professional qualification in relevant fields
- 3 to 5 years of work experience in regulatory work in Malaysia
- Excellent knowledge of the Malaysia medical device and cosmetics regulatory guidelines
- Motivated and result-oriented individual who thrives in a fast-paced environment
- Good presentation and communication skills
- Meticulous and good with details
About the Company
Neoasia Group
Neoasia is committed to seeking and distributing products that are clinically proven to be safe, effective and of highest quality.
Since its inception in 1995, Neoasia has been dedicated to bringing the most technologically advanced aesthetic equipment and skincare products to the medical community and consumers.
Priding itself as the setter for high standards in aesthetic technology, Neoasia recognizes the need for aesthetics practitioners to maintain their art at its peak. Combining cutting-edge technologies with exceptional relationships and premier services, Neoasia continues to keep their clients at the forefront of aesthetic trends, keeping their fingers on the pulse of global aesthetic market and bringing only the finest technologies that ensure safety and optimal results, all through science.
Neoasia's corporate headquarter is situated in Singapore, with our distribution networks extended to Malaysia, Brunei, Indonesia, Vietnam, The Philippines and China. Our secured geographical coverage of clinics, hospitals and retail outlets in the region is your guarantee to greater distribution and marketing services.