北京招聘

JOB RESPONSIBILITIES:

· Possess an in-depth understanding of the regulatory requirements in the responsible geographic areas

· Manage regulatory affairs submission for medical device manufacturers

· Develop and ensure an effective product registration strategies for customers

· Handle both internal and external regulatory compliance enquiries

· Establish and maintain good relationship with local regulatory health authorities

· Prepare standardized regulatory submission template based on commercial promotion needs



REQUIREMENTS:

· At least 3-5 years' regulatory affairs experience in medical industry, preferably from medical device industry

· Good understanding of the local medical device regulatory requirements

· Knowledge of ICH, GCP guidelines, ISO and global regulations,such as IEC62304,ISO25051,IEC/ISO12207

IEC 61508-3,IEC/ISO 90003 ...whilst product safety or QMS experience is a plus

· Must be a degree holder in medical related discipline

· Proficiency in both English and local languages

The UL family of companies is a premier global safety science company with more than a century of proven history, delivering top-quality safety and compliance services to thousands of customers. Founded in 1894, we are dedicated to promoting safe living and working environments and fulfilling our mission of working for a safer world. Today we employ almost 9,000 professionals in over 100 countries, and those numbers are growing.

UL’s technical and subject-matter experts are dedicated to advancing safety science in a borderless world, working within our five exciting businesses under one of the most recognized and respected safety brands in the world:

?Product Safety - product safety testing and certification
?Environment - independent green claims validation, product certification, training, advisory services and standards development
?Life & Health - innovative and trustworthy solutions to the drinking water, food safety, in-vitro diagnostic and medical equipment industries
?Verification Services – commercial testing, inspection and auditing, supporting manufacturing business operations from initial design through prototyping and into final production and enhances retail or go-to-market supply chain quality management operations
?University - facilitated workshops, online training including self-paced e-learning and live/on-demand webinars, white papers and industry reports, books and safety videos, customized training

We are proud of our role in public safety and work hard each day to help the world move forward – one safe step at a time. Together, we CAN make a difference, so if you’d like to make a real impact, make us your first choice!