Regulatory Affairs

3 days ago

Singapore SCHULKE & MAYR (ASIA) PTE LTD Full time

**Responsibilities**:

- 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
- 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

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