Principal Clinical Scientist

1. Responsibilities

1.1. Conducting site selection and qualification，Negotiating budget and contract with clinical sites.
1.2. Leading the development of clinical study protocol and reports.
1.3. Collaborating with Regulatory to prepare FDA pre-submission and submission packages.
1.4. Overseeing clinical sites, central lab, and other third parties to ensure issues are resolved timely.
1.5. Overseeing the clinical studies to ensure target timeline and budget are met.
 

2. Education and Experience

2.1. A Bachelor’s degree or equivalent in a life sciences, nursing, or related discipline. Advance degree preferred.
2.2. Minimum 10 years of clinical research experience for medical device and IVD products. Minimum 5 years’ experience with rapid self-test IVD products is required. 
2.3. Experience in communicating with the FDA.



Please Send your resume to [email protected]

Sales Manager

Job Responsibilities:
1. Client Acquisition and Sales Targets: Expand the retail industry customer base and achieve quarterly and annual sales targets.
2. Full-Service Management: Oversee the entire sales process from order placement to delivery, ensuring excellent service and promoting a strong company reputation.
3. Sales Team Development: Build and manage a high-performing sales team to drive business growth.
4. Market Research and Product Development: Conduct market research and analysis, refining existing products and expanding the product line based on customer and market feedback.
Job Requirements:
1. Educational: Bachelor’s degree or higher.
2. Background and Experience: Over 8 years of sales experience in the U.S. retail industry, with a focus on medical products. Experience in selling rapid tests is a plus.
3. Client Network and Sales Success: Proven track record of large-scale sales achievements, with strong connections in distribution, e-commerce, retail, or government sectors.
4. Attributes: Highly efficient, proactive, and responsible.
 


Please Send your resume to [email protected]

Regulatory Affairs Manager

Qualifications:
· Bachelor's degree or above in a relevant discipline required
· 5+ years of industrial experience in IVD or medical device FDA registration
· Proficiency in Chinese preferred
Tasks:
· Lead and support new product 510k Submissions
· Lead and support International Device Licensing and Registrations
· Support product development teams with new product submission requirements
· Provide guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
· Lead and support the implementation of clinical research projects
· Develop and support clinical sites management through all phases of the clinical trial
· Travel to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
· Ensure that documentation from clinical trial sites meets FDA/GCP/GDP requirements


Please Send your resume to [email protected]

Diagnostic Sales Representative/Manager

With deep expertise in diagnostics, GenaBio Diagnostics is creating solutions to address the needs of COVID, toxicology and other infectious diseases. Genabio is an exciting early stage company and brings together experienced scientists and industry veterans with a proven track record in diagnostic product development, marketing, and sales. Since 2020, we are working with leading partners in the United States including Quest Diagnostics, UCSF, Boston University, UNC Rex Medical Center, and many more labs on COVID-19 tests. 
Summary
Genabio Diagnostics is looking for a sales representative who is looking to add value to our growing organization. The individual should be highly motivated with a strong work ethic, outgoing personality and a understanding of biological laboratories. This position will be the first sales role for the company and the individual will contribute to many company workstreams including inside sales, logistics, and marketing.
Responsibilities：
1. Responsible for achieving product sales to new and established accounts to accomplish sales objectives and greater market penetration.
2. Creates a plan to achieve objectives through sales and servicing of customers in a prescribed territory. Schedules appointments and makes preplanned sales presentations to customers.
3. Makes regular visits to customer locations to gather information on orders and market conditions.
4. Develops customer and product focused presentation packages for sales.
5. Prepares sales reports and documents as required.
6. Follows up with customers to resolve any issues and ensure satisfaction.
7. Develops and maintains sales forecast and submits to management. Relays relevant market information to management.
Qualifications：
1. Bachelor Degree, preferred majoring in biomedical science
2. Chinese speaker is a plus
3. Good communication skills
4. Highly motivated and able to work independently
5. Professional demeanor along with excellent communication, presentation, negotiation, follow up and closing skills.
6. Willing to travel within USA
 


Please Send your resume to [email protected]

​​International Trade Sales Directors

Responsibilities:
1. Effectively achieve the individual and team sales targets of IVD related products of the company;
2. Actively expand overseas market, develop and maintain overseas customers and agents;
3. Responsible for the daily maintenance of customers, actively contact and visit customers as needed, independently responsible for business negotiation, signing contracts, and order processing, tracking and completion;
4. Participate in the after-sales service and coordinate the return and replacement of customers; Participate in quality problem analysis.
5. Responsible for the tracking and analysis of product sales, market and competitor information understanding and feedback;
6. Responsible for the information collection of sales market; Understand the relevant national policies, market users, competitors, channels and other information;
 
Requirements:
1. Bachelor degree or above, CET-6 or above, overseas study and working background is preferred;
2. International trade, biomedicine, foreign language and other related majors, at least 3 years working experience in international market customer development and sales of medical devices or diagnostic reagents;
3. Proficient in English, able to communicate with foreign businessmen face to face and correspondence;
4. Rich foreign trade sales experience, familiar with the market development status, excellent sales skills, strong market analysis and insight ability, strong foreign market sales ability;
5. Proficient in office, ERP and other office applications;
6. With efficient execution, strong pressure resistance ability, good professional and personal quality level, with the overall situation, sense of responsibility, team cooperation consciousness and spirit.

Please Send your resume to [email protected]

Diagnostic Reagent R & D Director / VP

Responsibilities:
1. Participate in the formulation of the company's medical laboratory reagent planning and R & D decision-making, and participate in the formulation of R & D system;
2. Responsible for the construction and management of in vitro diagnostic reagent R & D team;
3. Support the regulatory certification of products, including FDA, CE, and has in Singapore;
4. Provide necessary technical support and training to marketing and sales department;
 
Requirements:
1. Doctor degree in medical laboratory, clinical medicine, biology and immunology; Overseas study and working background is preferred;
2. At least 5 years working experience in IVD industry, and many years system management experience in R & D team;
3. Overseas study and R & D experience is preferred;
4. Strong ability of organization, coordination and leadership, strong ability of scientific research, rigorous and meticulous work, planned and organized. It can make effective use of resources.

Please Send your resume to [email protected]

US Account Manager

Responsibilities:
1. Responsible for the sales work in the U.S. region, selling the company's testing products (Covid, drug of abuse test and other) and related consumables, developing direct customer and dealer channels;
2. Actively contact and visit customers as needed, maintain customers daily, independently take charge of business negotiation, signing contracts, and order processing, implementation and implementation;
3. Participate in after-sales service. Participate in the coordination of customer return and exchange; Participate in quality problem analysis;
4. Responsible for the tracking and analysis of product sales, market and competitor information understanding and feedback.
 
Requirements:
1. Bachelor degree or above, living in Boston
2. International trade, biomedical and other related majors, 2 years of medical equipment or diagnostic reagent sales experience preferred;
3. English listening, speaking, reading and writing can reach the native language level, can communicate with unimpeded interviews and correspondence, and can accurately grasp the customer needs and market status;
4. Be proficient in using office and other daily office application software; Self discipline, high efficiency execution, strong compressive ability, good professional and personal quality, and a high sense of responsibility and teamwork.

Please Send your resume to [email protected]

IVD Product Manager

Responsibilities:
1. Conduct product research and collect market information and competitive product information of diagnostic reagents and instruments;
2. Preparation and compilation of new product marketing materials;
3. Participate in internal quality audit and quality document preparation, management, etc;
4. Follow up the production process and quality control of products;
5. Collect, sort out and maintain the regulatory requirements for product access in different countries, and be responsible for the writing and sorting out of the application materials for product registration in different countries;

Requirements:
1. More than 2 years of IVD or pharmaceutical industry related experience, overseas study and working background is preferred;
2. Bachelor degree or above in medicine, laboratory, pharmacy, biology, chemistry, etc
3. Fluent in English reading and writing, able to read and translate English materials independently;
4. Be familiar with foreign registration process of IVD reagents, ISO13485 and other relevant laws and regulations;
5. Positive working attitude, strong communication and coordination ability and sense of responsibility, strong planning and implementation ability.

Please Send your resume to [email protected]