RAQA Specialist, Singapore
4 weeks ago
Position title: RAQA Specialist, Southeast Asia
Department: RAQA
Reports to: RAQA Manager, Southeast Asia
About Applied Medical
As a new generation medical device company, we believe in the power of working together to make a meaningful and positive difference. Applied Medical is committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth. We are dedicated to creating an environment where team members of diverse backgrounds are valued, challenged and acknowledged. Applied Medical’s products have been serving the Asian markets for over 20 years. To build sustainable partnerships in particular to Southeast Asia (SEA) markets, we are investing in hiring Regulatory and Quality (RAQA) team members.
Overall responsibilities
The RAQA Specialist will be responsible for regulatory and quality projects and improvements to meet company goals. This includes ensuring compliance to Regulatory Affairs (RA), Quality Systems (QS) and Quality Assurance (QA) requirements in SEA markets for Applied Medical products by performing premarket and post-market activities. The specialist must be capable of working within a team environment, striving to meet or exceed customer expectations.
Essential duties
Obtain product registration approvals from relevant authorities according to organization'sregulatory plan and strategy in SEA by compiling dossier as per local medical device regulations and collaborating closely with Headquarter Premarket team and authorities/distributors.
Assess changes and its impact on registrations for changes initiated by Product Owner and communicate impact to relevant stakeholders. Prepare, submit, and obtain approvals in a timely manner for changes initiated by Product Owner for continued market access. Timely renewal of product registrations. Monitor, prepare, and support compliance to adverse events reports, recalls and other required post-market surveillance regulations. Participate in internal and external audits as required. Support the implementation and compliance of Quality Management System in Singapore. Keep abreast with changes in the regulatory environment in SEA. Perform additional duties and responsibilities as required by leadership.Other duties and responsibilities
Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions and decision making. Build necessary relationships with internal and external stakeholders. Support the Field Implementation team with relevant documents for tender submissions. Identify and implement systems to improve the overall efficiency of processes. Perform additional duties and responsibilities as required by leadership.Position qualifications
Knowledge, skills, and abilities
Effective in obtaining and maintaining Marketing Authorizations or Registrations for medical devices, including handling change management. Experience in performing post-market activities, such as adverse event reporting and handling of recalls. Competent in supporting QMS on-site and document audits. Preferred knowledge in ISO 13485, ISO 14971, ISO 60601, GDP. Familiarity with supplier control and experience working with 3PL and/or 4PL. Ability to work independently and as part of a team. Able to multi-task, organize and prioritize. Analytical, meticulous and detail oriented. Assertive and not afraid to ask questions. Friendly, good attitude, customer service oriented. Effective oral and written communication and presentation skills in English.Education
Bachelor’s degree in engineering, physical or biological sciences, regulatory, other technical
discipline, or equivalent preferred.
Training in Quality Systems including GDPMDS.
Experience
1-2 years of experience in Regulatory Affairs and/or Quality Assurance in the medical device
Industry.
Materials
General office equipment
Microsoft Office Suite
SAP
Adobe Suite
Internet
Working environment
Hybrid work environment
Location: Singapore
Benefits
Applied offers benefits package following local labor laws
-
Coffee Specialist
1 hour ago
Singapur, Singapore Nespresso Full timePOSITION SNAPSHOT Location: Assigned Nespresso Boutique Company: Nespresso Singapore Full-time 2 years of experience POSITION SUMMARY As our Coffee Specialist, you will act as our ambassador for the Nespresso in the Boutique to welcome, advise and guide a clientele loyal to up-market products in compliance with the quality standards defined...
-
Singapur, Singapore GovTech Singapore Full time[What the role is] We are a close-knit, high-performing, and multi-disciplinary research division in Singapore Public Service. We are expanding and are recruiting a Senior/Research Specialist to work with a range of research initiatives in Singapore’s social service sector. Specialising in longitudinal and birth cohort studies, our team conduct research in...
-
Infectious Diseases Specialist
1 month ago
Singapur, Singapore Khoo Teck Puat Hospital Full timeAssociate Consultant / Consultant / Senior Consultant The Division of Infectious Diseases provides consultation on infectious disease related matter for both inpatient and outpatient services in Yishun Health. We are also actively involved in Infection Control and Antimicrobial Stewardship Program of our hospital. We are seeking accredited Infectious...
-
Senior Specialist
4 weeks ago
Singapur, Singapore GovTech Singapore Full time[What the role is] The National Library Board (NLB) nurtures Readers for Life, Learning Communities and a Knowledgeable Nation by promoting reading, learning and history through our network of 28 libraries across Singapore, the National Library and the National Archives of Singapore. At NLB, you can look forward to a flexible, hybrid work environment with...
-
Sales Specialist
2 days ago
Singapur, Singapore Barsan Global Logistics Full timeSales Specialist - Freight ForwardingWe are now seeking a full-time Sales Specialist to join our team at Barsan Global LogisticsThe main responsibilities will be: Developing freight pipelines to achieve sales targets for the Company.Increasing profitability by the growth of sales of services such as customs clearance, sea freight and air freight.Working...
-
Cycling & Technical Specialist - Singapore
1 month ago
Singapur, Singapore Specialized Asia Pacific Pte. Ltd. Full timeCycling & Technical Specialist - Singapore JOB SUMMARY A critical member of the team, the Service Technician balances a passion for people, a broad technical expertise, and excellence in retail practices. A Service Technician is the front line and point person for our brand to the rider and encourages successful, profitable retail by taking their technical...
-
Senior Quality Assurance
4 weeks ago
Singapur, Singapore Align Technology Full timeAbout this opportunity The APAC Regulatory and Quality Assurance Department has a position in APAC for a Senior Quality Assurance (QA) Manager to support the region Quality Management System. This role will lead, establish, maintain, coordinate and support APAC Quality Assurance in meeting Align’s Quality goals via an effective Quality Management System to...
-
Kitchen Renovation Specialist
1 month ago
Singapur, Singapore Kitchen Renovation Singapore Full timeKitchen Renovation Singapore is a top-notch kitchen makeover service in Singapore. We're all about making kitchens better! Our experienced team focuses on giving you the best kitchen revamp that suits your needs. We pay attention to details and work hard to make sure you're super happy with the results. Your satisfaction is our priority, and we take pride in...
-
Executive Administrator
4 weeks ago
Singapur, Singapore Koudai Network Services Full timeExecutive Administrator (Singapore) Job Ref: S0365 Job Level: Specialist Executive administrator is responsible for the administrative tasks of corporate executives. In this position, one can expect to conduct research, create statistical reports, and prepare agendas for top management. Other tasks may include overseeing the office budget and ordering...
-
Customer Experience Specialist
2 days ago
Singapur, Singapore Porsche Singapore Pte. Ltd. Full timeTasksTasks Porsche Singapore is offering a vacancy as Customer Experience Specialist within its Marketing team. The Customer Experience Specialist is responsible for delivering a professional, prompt and best-in-class service experience to customers across various communication channels. This role aims to create excitement and build trust, ultimately...
-
Customer Service Specialist – English
4 weeks ago
Singapur, Singapore Agoda Full timeThe Opportunity: If you are looking for a rewarding and exciting career in customer service, we want you! We are currently looking to recruit Customer Experience Specialists to be based in our Singapore office. This is a fantastic opportunity to develop your customer service skills while working for a fast-paced company that invests in its...
-
Customer Experience Specialist – English
1 month ago
Singapur, Singapore Agoda Full timeThe Opportunity: If you are looking for a rewarding and exciting career in customer service, we want you! We are currently looking to recruit Customer Experience Specialists to be based in our Singapore office. This is a fantastic opportunity to develop your customer service skills while working for a fast-paced company that invests in its...
-
Senior Research Specialist, Sector Research
1 month ago
Singapur, Singapore GovTech Singapore Full time[What the role is] We are a close-knit, high-performing, and multi-disciplinary research division in the Singapore Public Service. Our work includes longitudinal/panel and birth cohort studies, environmental scanning and sense making, evaluation at the sector, fund, and programme level, and economic evaluation. We operate in various areas ranging from family...
-
Singapur, Singapore KPMG - Singapore Full timeJob DescriptionThe Cloud Security Specialist role is within the Cyber security department of KPMG. The Cloud Security Specialist will help KPMG's clients to define systems security architectures using various cloud security technologies with a focus on AWS, MS, GCP suite of products. The Cloud Security Specialist will be required to support business...
-
Senior/ Regulatory Specialist
2 weeks ago
Singapur, Singapore GovTech Singapore Full timeWe are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Senior/Regulatory Specialist. Evaluate the clinical data for therapeutic product applications for regulatory approval to assure the efficacy and safety of medicines supplied in Singapore Handle enquiries and provide guidance on the...
-
Cybersecurity Specialist
4 weeks ago
Singapur, Singapore GovTech Singapore Full timeDescription IMDA is spearheading Singapore’s drive to be a world leading Digital Economy. IMDA aims to empower our companies and workforce with digital technologies and enable Singapore to be a leading Digital Economy. We are currently seeking a Cybersecurity Specialist with expertise in Quantum Safe Communications to join our team and help secure...
-
Singapur, Singapore Khoo Teck Puat Hospital (KTPH) Full timeJob Description As a Staff Nurse, you will: join a team of well-trained professional staff to administer personalised and quality person-centred care in specialist clinics. provide professional nursing care, educate patients and their family and perform related duties as required. supervise and coach a team of nurses to provide optimal care and...
-
Marketing Specialist
3 weeks ago
Singapur, Singapore MDPI Full timeTo strengthen our marketing team and build the market in Southeast Asia, we are looking for Marketing Specialist who are eager to stay connected to scientific research and promote academic publishing service in academic field. The position of Marketing Specialist is a full-time position based in Singapore. Responsibilities and Main Duties: ...
-
Singapur, Singapore Khoo Teck Puat Hospital Full timeAs an Enrolled Nurse, you will: join a team of well-trained professional staff to administer personalized and quality person-centered care in specialist clinics. provide professional nursing care, educate patients and their family and perform related duties as required. be provided with opportunities for training and development. Job Requirements Hold a...
-
Application Support Specialist
4 weeks ago
Singapur, Singapore Cognizant Full timeIf you have DevOps or software developer experience and you’re seeking a new role in Singapore, we want to hear from you. Cognizant is recruiting an Application Support Specialist, and the full-time role comes with an attractive salary and benefits package. As an Application Support Specialist, you will work closely with data and product owners to ensure...