- RoHS EU Directive 2011/65/EU as amended by 2015/863/EU
- China RoHS (Administrative Measure on the Control of Pollution Caused by Electronic Information Products, UAE RoHS)
- REACH: EU Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (as amended)
- WEEE: Directive 2012/19/EU (Waste Electrical and Electronic Equipment)
- EU MDR: Section 10.4 of the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- Ensure BA US products (including Transducers and Catheters) are using Biocompatible materials as required by ISO10993
- Having proper knowledge for assessing Biological Evaluation of BA US products (including Transducers and Catheters)
- Participates in Healthineers level PREP working groups providing input into corporate level directive and requirements and supporting the development of shared tools and processes.
- Ensures the Ultrasound division complies with Healthineers corporate PREP directives & requirements.
- Owns and manages Ultrasound-specific PREP policies and procedures.
- Manages division level activities and timelines related to Healthineers corporate PREP projects.
- Provides timely internal PREP related reporting for the Ultrasound Division and Healthineers.
- Responsible for timely reporting of any material compliance issues to Healthineers corporate material compliance experts. Determines proper containment and disposition activities as required based on the compliance risk.
- Provides requested PREP information to support sales quotations.
- Responds to customer questions regarding product substances and other PREP information.
- Manages processes to document material compliance for product declaration of conformities.
- Ensures processes are maintained for assuring PREP requirements are reviewed and verified throughout the product lifecycle process.
- BA/BS engineering or material science degree with a minimum of 5 years of experience being actively engaged in implementing regulatory compliance regulation.
- Program & Project Management experience is need for successful outcomes.
- Medical Device experience will be highly weighted.
- Lean Six Sigma experience will be highly weighted.
- SAP experience for navigation to product specifications, ECOs, data field inputs, etc. and/or experience with material compliance software such as BomCheck; Silicon Graphics or similar software is a plus.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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