Manager - Codes & Standards招聘 - 科勒（中国）投资有限公司

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.