About Us
Artron BioResearch Inc is a technology-based manufacturer specialized in the development and large-scale production of antibodies and antigens. Employing the best practices in developing rapid diagnostic technology has given the company invaluable hands-on expertise to provide our clients with the best-matched pairs of monoclonal antibodies and recombinant antigens in the industry. At Artron, we are committed to going above and beyond to meet the rapid diagnostic industry participants’ specific challenges. Our focus on guiding our customers every step of the way allows our clients to receive the best in class customer service.
We are looking for a bright, highly organized individual to join our team! At Artron, we offer a competitive salary and benefits package, dental and vision extended health insurance, a flexible and friendly working environment, year-end bonus, free holiday gifts.
KEY RESPONSIBILITY
- Facilitates Artron’s products through the investigational studies and approval process, including preclinical and clinical support, pre-submission assistance, application submission and maintenance (e.g. IVD I/II registration project).
- Assists in reviewing and revising product labeling artwork including product labels for pouches, boxes, and instructions for use in accordance with the governing regulations and the company procedures.
- Coordinates and collects information from various departments (e.g. R&D, Product Development, QA etc.) to support regulatory projects.
- Participates in the review of new regulations and development of internal procedures.
- Assists in doing research and drafts technical documents for regulatory submissions.
- Assists with particular regulatory assessments when required.
Education and Experience:
- Bachelor’s degree in Life Science related study fields.
- 1+ years of experience working in biological, pharmaceutical and medical device industry.
- Skilled in MS Office computer applications.
- Multitasking skills and willingness to actively seek information necessary to complete assignments.
- Excellent interpersonal skills at work.
- Excellent verbal and written skills in English.
Job Types: Full-time, Permanent
Benefits:
- Dental care
- Extended health care
- Vision care
Schedule:
- 8 hour shift
Education:
- Bachelor’s Degree (required)
Experience:
- Medical Regulatory Affairs: 3 years (required)
Language:
- Mandarin, Chinese (preferred)