贵阳招聘

Job Summary

• To responsible for product registration on assigned segment(s).

· To maintain relevant RA work for database, bidding documentation for RA portion.

· To handle labeling database

· To assist and support the RA Manager for RA plan, strategy and other related RA duties.

Principal Duties and Responsibilities

50 § Responsible for assigned segment(s) of medical device products register in china, include initial and extension registration, variation, IFU filing at NMPA make sure submission is correctly and timely.

25 § Follow up product testing, evaluation procedure, solve problem timely and efficiently. Keep well Communicate and relationship with relevant authority & testing center.

15 § Responsible for assigned RA duties. Such as database maintain, bidding documentation supply for RA portion.

5 § To track new regulations / standards or changes health agencies and evaluate the business impact to commercial or company. Familiar with relevant regulation & policy in RA field.

5 § Provide regulatory support to co-departments or teams in explaining Chinese regulation and give input base on the requirement.

100 Total Percent (not to exceed 100%) *Individual percent should be greater than or equal to 5%.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the .

Expected Areas of Competence (i.e. KSAs)

§ Good communication skill.

§ Effective problem solving, organizing and planning capabilities

§ Good teamwork and actively attitude.

§ Effectively managing one’s time and resources to ensure that work is completed efficiently.

Education/ Experience Requirements

§ Bachelor degree or above in Biomedical Engineering, electric or equipment or other related sciences.

§ At least 3 years working experience in the field of medical device (Preferred to active-MD or equipment area)

§ Professional knowledgeable on regulatory affairs field.

§ Computer skills and be proficient with commonly used software.

§ Good at written and oral in English.

Travel Requirements

20%

捷迈邦美成立于1927年，总部设立在美国印第安纳州华沙镇，是骨骼肌肉保健行业的全球领导者。我们的经营范围包括：设计、生产和营销骨科置换产品；运动药物、生物制剂、肩肘足踝产品和创伤产品；脊椎、骨折愈合、颅颌面和胸椎相关产品；牙科产品；以及手术工具产品。

我们同全球医务人员合作、加速创新。我们致力于提供产品和解决方案帮助患者治疗骨骼、关节或支持软组织疾病。通过同医务人员合作，我们成功给数百万人带去了福音。

我们在全球超过25个国家经营业务，产品销售到100多个国家。关于更多信息，请访问****************或登录推特网关注捷迈邦美，网址***********/zimmerbiomet.

捷迈（上海）医疗国际贸易有限公司自2011年起连续4年被评为中国杰出雇主奖，捷迈注重为员工提供优异的雇员福祉，注重培养发展组织内各级别的人才。

We offer an attractive remuneration package & good carrier development opportunities to the successful candidate. Please send your resume, recent photo, copy of certificates and ID card to the company address.