Total 4 job vacancies by CorDx

Job Responsibilities:

• Build, develop, and maintain strong customer relationships with business partners, including academic and public institutions, hospitals, major clinic chains, pharmacies, dealers, and agents.
• Generate repeated sales and cultivate long-term, value-driven collaborations.
• Provide market feedback and implement relevant sales strategies.
• Establish and maintain a positive company image and customer relationships, including developing key customers.
• Exhibit excellent market sensitivity and adaptability to market changes.
• Regularly summarize and analyze sales results, submitting relevant data and reports.
• Manage and respond to queries from potential customers and follow up on leads and referrals.
• Collaborate closely with the Sales team on sales plans to achieve or exceed sales targets through value creation selling activities.
• Stay updated with product knowledge and informed about competitors’ products.
• Provide accurate forecasts, pipeline data, and market intelligence on competitors to management.
• Maintain an up-to-date customer list with contact details.
• Lead and manage the sales team's KPIs, ensuring timely achievement of targets.
• Collaborate with cross-functional leadership teams to align business development goals with overall organizational objectives.
• Perform any other ad-hoc duties or projects within the sales and marketing function as required by the management team.

Qualifications:

• Strong network in the medical device and pharmaceutical business.
• A Bachelor Degree with at least 2 years of relevant experience (others are welcome to apply).
• Familiarity with in vitro diagnostic products such as lateral flow immunoassay, PCR, and Immunoassay.
• Understanding of IVD product development and commercialization lifecycle.
• Strong project management skills, including planning, execution, and timely communication.
• Excellent presentation skills.
• Preferred majors: biology, medicine, laboratory science, immunology, pharmacy, or quality engineering.
• Enthusiastic, proactive, and down-to-earth work attitude with strong communication and execution abilities.
• Results-driven and a team player.
• Meticulous with a strong sense of responsibility, able to handle stress and tight schedules.

Job Description:

1. In charge of the preparation of reagents, calibration materials, and quality control products, strictly follow SOP, keep all records in the receipt, review, and use of raw and supplementary materials, monitor the stock condition and work with procurement team to replenish accordingly.

2. Responsible for the collection and bookkeeping of raw materials, auxiliary materials, packaging materials, etc. for production.

3. Responsible for filling in production logbook to ensure that the data is true, complete and accurate.

4. Ensure production equipment, facilities and production environment can meet production process and regulatory requirements.

5. Ensure employee working environment and quality in strict accordance with the system and regulatory requirements.

6. Strictly comply with laboratory-related operation and quality management requirements.

7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.

8. Any other ad-hoc duties or projects as required by the management team.

Job Requirements:

1. Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.

2. A bachelor's degree. Fresh graduates are welcome to apply.

3. Experience in IVD, controlled environment production, quality system, R&D and etc.

4. Expertise in the operation and maintenance of lab instruments and data systems.

5. Understand the relevant requirements of the production quality system for in vitro diagnostic products.

6. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.

7. Familiar with IVD product development and commercialization life cycle.

8. Systematically project management, good planning, execution and timely communication. Good presentation skills.

9. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.

10. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

1. A bachelor's degree in in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Job Responsibilities

1. Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment.
2. Perform incoming, in-process and final QC inspection.
3. Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation.
4. Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department.
5. Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment.
6. Be specifically responsible for the IVD equipment quality management system.
7. Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures.
8. Update quality standards, laws and regulations and publish company quality policy.
9. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
10. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
11. Any other ad-hoc duties or projects as required by the management team.

1. Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.
2. A bachelor's degree with 2 years of relevant experience, others are welcome to apply.
3. Quality system related training and internal auditor training.
4. Familiar with US FDA 820 & ISO13485 quality management system and ISO 13485 certification work, experience with successful case(s) will be preferred.
5. Familiar with medical device industry standards and specifications.
6. Strong quality management system knowledge and capabilities.
7. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
8. Familiar with IVD product development and commercialization life cycle.
9. Systematically project management, good planning, execution and timely communication. Good presentation skills.
10. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
11. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.