Technical Document Engineer
This position will primarily focus on technical writing of R&D and/or Quality documentation to make it suitable for regulatory submissions or quality audit. Other duties include but not limited to regulatory documentation management, global registrations, create or improve regulatory and/or quality processes.
WHAT YOU’LL DO
1.Work with cross-functional teams, especially with R&D team to support technical documents writing.
2.Communicate details with R&D team member(s); Design, create, and organize content for R&D documentation .
3.Work with R&D and Marketing to author product Instruction of Use or User Manual as to meet regulatory requirements and customer need
4.Review labeling and advertising promotional materials.
5.Manage labeling changes and versioning.
6.Maintain regulatory documentation in proper database; create efficient regulatory information management process in order to support global registrations and regulatory planning timely
7.Track and monitor global regulatory applications/pre-market submissions and registration status.
8.Track and maintain licenses, registrations, and/or listings after approval
9.Global regulatory management for product changes
10.Compile international regulatory submissions
11.Review product design and quality documentation and provide regulatory advice or guidance to other functions
12.Assist compliance with Quality System requirements and product post market approval requirements.
13.Participate in regulatory SOP development and improvement.
14.Monitor new or updated regulation and guidance for the responsible regions, assess impact to the business and provide solution.
1.Excellent English oral and written communication skills
2.Skills/experience with document writing in English, highly organized, detail oriented, and have a high regard for quality
3.Bachelor's Degree in English or science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, or engineering)
4.Demonstrated ability of good communication, coordination and team work with people from various disciplines and cultures.
5.Demonstrated ability of computer operation. Proficient in WORD, PDF, Framemaker, Arbortext, Xmetal，EXCEL, POWERPOINT and other office software;
1.Work experience in registration/R&D/Quality/clinical trial in healthcare industry
2.Work experience at an oversea enterprise