深圳招聘

职位描述：
Senior Regulatory Specialist


RESPONSIBILITIES:
? Responsible for the product registration and existing cert maintenance in order to manage the new product registration schedule and maintain the validity of product licenses and certificates.
? Organize, maintain and update all technical and registration files, any regulatory relevant documents (eg., licences, certificates)
? Review product labeling, product inserts and promotional & marketing materials in order to ensure compliance with regulations
? Update the regulatory requirement within AP region and provision of updated regulatory guidance to marketing, product development and logistic teams
? Monitoring the post-market surveillance and incident reporting within AP region and provide advice / recommendation on regulatory and quality issues to the immediate supervisor for appropriate actions

QULIFICATIONS:
? Bachelor Degree or above in Science, Engineering, Medical Service, or other relevant program
? Min 5 years relevant experience in RA field with at least 2 years hands on experience in registration for medical device
? Strong knowledge in CFDA, CE, FDA and Health Canada
? Familiar with the medical device registration process
? Good technical writing and communication skills in Chinese and English
? Good interpersonal and negotiation skills
? Fluent in Chinese and English (both verbal and written)
? Excellent communication and reporting skills 举报 分享

Helen of Troy (*******************, NASDAQ:HELE) incorporated in Texas in 1968 and were reorganized in Bermuda in 1994. We are a leading global consumer products company offering creative solutions for our customers through a diversified portfolio of well-recognized and widely trusted brands. We have built leading market positions through new product innovation, product quality and competitive pricing.
We have three business segments:
Housewares. Provides a broad range of products to help with food preparation, cooking, cleaning, organization, beverage service, and other tasks to ease everyday living for families. Sales for the segment are primarily to retailers, with some direct-to-consumer product distribution.
Health and Home. Provides healthcare and home comfort products. Sales for the segment are primarily to retailers, with some direct-to-consumer product distribution.
Beauty. Provides personal care, beauty care and wellness products including hair styling appliances; grooming tools; decorative haircare accessories; and liquid-, solid- and powder-based personal care products. This segment sells primarily to retailers and beauty supply wholesalers.

We are a dynamic, growing company that offers challenges and opportunities equal to your talents and abilities. If you’re seeking an exciting, professional position in a company that allows outstanding performers to achieve their potential, Helen of Troy will be a great choice for you.