Total 1 quality assurance control job vacancies in Singapore

Responsibilities:

· Manage regulatory affairs for the organization including new product registrations, product notifications, product variation applications and transfer of product licenses in Asia Pacific region (mainly ASEAN countries and support Australia entity as a liaison to Headquarter on regulatory matters) where the organization has its activities in

· Obtain timely renewal of product licenses and maintain registration database

· Ensure appropriate licensing, regulatory, marketing and legal compliance of products in each country with the support of local regulatory/distribution partner

· Liaise with regulatory bodies and distribution partners in the region to maintain product licenses to allow sales activities in these countries

· Ensure product labels and materials are compliant with regulatory requirements

· Collaborate with Global RA team, active communicate across departments and coordinate with distributors and regulatory consultants to achieve timely application submission

· Provide training on regulatory and quality topics when necessary

· Ensure compliance of local government requirements and responsible for QMS maintenance and update for entity e.g. Good distribution and practices for medical device.

· Responsible for quality review and batch test reports for quality release

· Responsible for internal audits across entities and external audits with warehouse partners, manufacturing suppliers

· Lead for outsourcing projects where tech transfers, quality audits and preparation of dossiers are necessary working with key stakeholders in Quality and regulatory departments of manufacturers and respective local requirements

· Provide regulatory strategies for new products and any changes in targeted markets

· Setting up SOPs and ensure product quality and feedback on quality are well managed

· Supervise and guide 1 x Regulatory Affairs and Quality Assurance Executive

Requirements:

· Possess relevant Degree with at least 5-8 years of Regulatory Affairs/Quality Assurance experience working for medical device companies

· Possess knowledge of regulatory guidelines and requirement of countries in ASEAN as well as Quality Management System and GDPMD.

· Experience in audits and well verse in requirements on cosmetic GMP, ISO13485 and WHO GMP requirements

· Experience in tech transfer and manufacturing process is preferred

· Available on a short notice