(Sr.) Manager - Codes & Standards
科勒(中国)投资有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司
职位信息
- 发布日期:2021-06-04
- 工作地点:北京-密云区
- 招聘人数:1人
- 工作经验:10年以上经验
- 学历要求:硕士
- 语言要求:英语精通
- 职位月薪:3.6-6.2万/月
- 职位类别:认证工程师
职位描述
Manage K&B Codes & Standards in China for all product categories reporting into Global Codes & Standards Leader.
1. Ensure K&B codes and standard are up to date & accessible globally.
1.1 Manage product regulatory, codes & standards for US, Canada, Europe, India, Middle East, Mexico, Latin America, China, S. Korea, Thailand region & other APAC region.
1.2 Understand and interpret codes, standard and regulatory requirements for Kohler K&B products.
1.3 Acquire knowledge and stay upto date on current certification requirements and processes for Kohler K&B products.
1.4 Deploy accurate and reliable system of communication for updates and Compliance within K&B.
1.5 Risk assessment and relevance analysis of regulatory standards, impact on products and implementation strategy in K&B.
1.6 Development of the training for engineering and support continuous competency enhancement of Advance Development & Engineering team on C&S.
1.7 Make communications/relationships with Standard governing bodies.
2. Coordinate with Compliance & Product Engineering regulatory changes affecting K&B products sold globally.
2.1 Work with global Product compliance team for updates /new standards and assess impact on K&B products.
2.2 Communicate with the NPD/Advance development engineering organisation on Codes, Standards & regulation updates and addition where relevant.
2.3 Guide the product teams through Certification processes.
2.4 Facilitate audits by government and certification agencies.
2.5 Leading and helping team to navigate through agency review, submission, and approval processes.
2.6 Familiarity with CSR (not limited to): ISO 13485, IEC-60601, ASTM Standards, HIPAA, RoHS, REACH, EMC, etc.
2.7 Certify products with various agency (not limited to), e.g. IAPMO, CFDA, China National Medical Products Administration, FDA, Health Canada, Notified Bodies for Medical Device Directive (EU), COFEPRIS (MX), PMDA (Japan), ANVISA (Brazil), etc.
2.8 Complete Performance Evaluation Reports (PERs) and Clinical Evaluation Reports (CERs)
3. Assist with the application of Codes & Standards in first time to KOHLER products, Technologies, countries.
3.1 Support creation of new product standards for “first time in KOHLER” products or technology application, includes performance, compliance & Safety.
3.2 Revision of product standards as needed supporting the product / AD engineering teams.
3.3 Create repository of standards controlling the central database for Engineering.
3.4 Support NPD for Codes, Standards, and compliance.
职能类别:认证工程师
公司介绍
微信关注“科勒KOHLER微招聘”获得科勒最新招聘信息。
联系方式
- Email:nanchang@kohler.com.cn
- 公司地址:江干区环站东路777号东站西子国际B座509-510室
- 电话:15201917582