贵阳招聘

Job Summary

• To be a key contact between global BU and local distributor for any regulatory affair related.

· Track new regulations / standards or changes health agencies and evaluate the business impact. Provide interpretation of regulations and requirements

· To provide relevant RA work for database maintains and documentation archive.

· To assist and support the RA Manager for related project strategy analysis and implementation

Principal Duties and Responsibilities

45 § Handle registration projects including implant and instrument to get new, renewal approvals. Responsible for handling projects for those field notification impact to get CFDA variation approvals to maximize the reduction of business impact for business.

25 § Follow up product type testing, evaluation process, Solve problem/technical issues timely and efficiently. Keep well communications both for external relevant authority, testing center and internal environments.

15 § Responsible for assigned RA duties, such as database maintains and documentation archive

10 § Provide regulatory support to co-departments and global BU in explaining Chinese regulation and give input per their requirements.

5 § To track new regulations / standards or changes health agencies and evaluate the business impact to commercial and regional/corporate regulatory functions. Familiar with relevant regulations & policies in RA field.

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 skills.

§ Effective problem solving, organizing and planning capabilities

§ Good teamwork and actively attitude under pressure.

§ Effectively managing individual time and resources to ensure task is completed efficiently.

§ Actively participating as a member of a team to move the team toward the completion of goals.

Education/ Experience Requirements

§ Bachelor degree or above in Biomedical Engineering or related sciences.

§ Above 2 years working experience in the field of medical devices.

§ Professional knowledge 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.