QA/ra Specialist

**POSITION PURPOSE**:
This individual is responsible for the processing all regulatory affairs matter related to the product life cycle from premarket to post market activities, advising the team on appropriate regulatory procedures to ensure products are legally marketed in the respective country. The incumbent is responsible to draft a regulatory submission and work with the respective authorized market representative in the submission of premarket approval ensuring the device is safe and effective for its intended uses. The incumbent is responsible for reviewing all the product labeling associated with the product and ensuring all claims are consistent with the approved intended use and all materials associated with the device are appropriate. The incumbent is competent to interact with local and international regulatory bodies such as HSA, FDA, TGA, etc. The incumbent will also cover QA tasks as assigned.

**DIMENSIONS**:
The incumbent is responsible for assisting the QA/RA Manager in preparation of all documents required for the registration and renewal of product in new and existing markets. The incumbent will work closely with the market authorized representative to understand the market regulatory requirements and work with the appropriate function in the company to implement those requirements by incorporating it into the quality management systems as applicable.

**NATURE AND SCOPE**:
A. Report Relationship - This position reports directly to the QA/RA Manager.

B. General Department Overview - The incumbent provides regulatory and quality assurance support to the company in obtaining the market regulatory requirements and communicate to all relevant functions for implementation of the requirements, working all other departments, ensuring SOP & requirements are met. Ensuring product registration process is adequate and prompt.

C. Areas of Responsibility: **Primary Functions**
- Product registration and dossier preparation.
- Working with market authorized representative on product registration and renewal.
- Ensure local and international market regulatory requirements are in compliance (HSA, TGA, FDA, EU, NMPA China, others as applicable).
- Participate in regulatory inspection by the regulatory authorities and certification bodies.
- Ensure all technical documents are updated and ready for regulatory submission. Translation from English to Chinese or vice versa is required.
- Any other tasks or projects that are being assigned by the immediate supervisor, as and when required.

**General Support Functions**
- Update monthly report.
- Process purchase requisition for registration and associated fees.
- Follow-up on any pre-market information and data required for dossier submission for new product registration.
- Assist in data collection from market authorized representatives for post market surveillance.
- Preparation of Post Market Surveillance, Declaration of Conformance, Essential Requirement, Vigilance, Adverse Event Reporting, MDR certification.
- Participate in the internal and external quality audits, and inspections.
- Communicate any changes in market regulatory requirements to all relevant functions with an action plan and timeline for implementation.

D. Challenges of Position - The position requires the incumbent to be self-motivated to keep up with the current regulations and standards requirements and independent decision-making.

E. Communication Network - The incumbent must be able to communicate with local and international regulatory authorities, customers and all level within the company with fluent English and Chinese language.

F. Measurement - The incumbent will be measured by success in achieving good QA and Regulatory affairs’ results in successful product registrations, regulatory audits and good product quality.

G. Requirements (minimum qualification and competencies) - Diploma/Degree in Life Science (Pharmacy, Biology, Chemistry, Pharmaceutical). In-depth knowledge of the cGMP, market regulations (HSA, FDA, TGA, CFDA, EU) and ISO 13485. Understanding of law, regulation and pending regulation. Good communication, technical writing and interpersonal skills.