Ra&qa Executive
1 week ago
**THE ROLE**:
The RA&QA Executive will be responsible for regulatory compliance of IVD devices and related products according to relevant medical device regulations. Also, the RA&QA Executive will also be acting as a cross-department liaison with internal and external stakeholders, including distributors in the ASEAN region.
**OVERVIEW OF KEY REPONSIBILITIES**:
- Responsible for preparing and submitting product registration for Class A to D IVD with health authorities in a timely manner
- Perform RA activities pertaining to product certification through renewal, licence amendments and new registration for the ASEAN region
- Work in tandem with the Global RA team, requesting support as necessary while overseeing the administration of local regulatory systems and processes
- Extend regulatory support to other departments such as marketing and sales colleagues
- In charge of QMS management and post-market surveillance activities including FSCA, CAPA, recall management and customer complaints
- Support internal and external quality audits
- Oversee quality assurance of product importation, labelling, warehouse and distribution
**REQUIREMENTS**:
- Relevant Bachelor’s degree e.g. Engineering, Biomedical Sciences
- At least 3-5 years’ experience in the medical devices industry with regional responsibilities
- Demonstrated success in regulatory submissions
- Knowledge of SS 620:2016 GDPMDS or ISO 13485
- RAPS certifications is an added advantage
**HOW TO APPLY**:
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
-
Senior Automation Engineer
2 weeks ago
Singapore Pfizer Full timeSenior Automation Engineer - AMPS page is loaded## Senior Automation Engineer - AMPSlocations: Singapore - Tuastime type: Voltijdsposted on: Vandaag geplaatstjob requisition id: ## Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.# # **Why Patients Need You**Whether...
-
Senior Automation Engineer
1 week ago
Singapore Pfizer, S.A. de C.V Full timeWe're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place. To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those...
-
Senior Automation Engineer
2 weeks ago
Singapore Pfizer, S.A. de C.V Full timeWe’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about...
-
QA/ra Associate Specialist
10 hours ago
Singapore Zimmer Biomet Full time**Requisition Number**: APAC05208 **Employment Type**: Full-time **Location**: Singapore **Principal Duties and Responsibilities**: Regulatory Affairs - Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives. - Define and implement product registration approval strategies and plans. - Manage...
-
QA/ra Associate Specialist
10 hours ago
Singapore Zimmer Biomet Full time-Requisition Number APAC05208 Employment Type Full-time Location Singapore **Job Summary**: **Principal Duties and Responsibilities**: - Regulatory Affairs- Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives. - Define and implement product registration approval strategies and plans. -...
-
QA/ra Associate Specialist
10 hours ago
Singapore Zimmer Biomet Full time**Requisition Number**: APAC05060 **Employment Type**: Full-time **Location**: Singapore **Job Summary**: **Principal Duties and Responsibilities**: **Regulatory Affairs** - Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives. - Define and implement product registration approval strategies...
-
Product Category Executive
1 week ago
Singapore OMRON HEALTHCARE SINGAPORE PTE LTD Full timeThe Executive - Product Category supports in developing, implementing, monitoring, and evaluating marketing plans for multiple product ranges in the APAC region. This role aims to achieve sales objectives in the short to mid-term while ensuring product category growth and profitability. The executive will lead in driving the product category's targets, lead...
-
QA Executive
2 weeks ago
Singapore T. & C. MANUFACTURING COMPANY PRIVATE LIMITED Full timeT & C manufacturing Co. Pte Ltd is recruiting for Quality Assurance Executive. Job Descriptions - Maintain and improve quality assurance system, FSSC 22000, etc. - Assist QA HOD in maintaining GMP practices, and conduct trainings related to Food Safety, Quality Assurance, Halal related topic. - Assist QA HOD in internal audit, external audit, assist in...
-
Singapore Novartis Singapore Full timeRegulatory Affairs Executive Director, RA Head Most of World About The Role As the Regulatory Affairs Executive Director, RA Head Most of World region, based in Singapore, you will play a pivotal leadership role in shaping and executing regulatory strategies across a diverse and dynamic region encompassing Asia Pacific, the Middle East, and Africa. Summary...
-
QA Executive
1 week ago
Singapore Jumbo Group Of Restaurants Pte Ltd Full timeWe are looking for the right candidate for the position of QA Executive to grow with us. You will be responsible for: Assist in implementation and management of food safety (HACCP & ISO 22000) & quality assurance programmes in Central Kitchen & outlets (local & overseas)Training of staff in Standard Operating Procedures (SOPs), food hygiene and food handling...
