Job Description :
Title: System Engineering (Quality and regulatory)
Location: Plano, Texas
Required Experience/Skills:
- At-least 5-6 years in medical quality and regulatory environment
- Ability to work as a SME and ability to undertake MDR service offering
- Ability to understand product functionality and identify associated product and process standards needed for it compliance in various market like 510K, EC and Japan markets.
- Experience in the product standards for verifying whether the compliance of the product is completed in it verification stage.
- In-depth expertise in application of ISO 13485 and ISO 14971.
- Working knowledge of ISO 60601-1-X, ISO 62304, ISO 62366, brief knowledge of ISO 60601-2-X standards
- Standards for biocompatibility ISO 10993, packaging, transport and sterility.
- Understanding of clinical parameters associated with product.
- Understanding of labelling requirements as per MDR/UDI, tools to create them.
- Thorough understanding and experience of manufacturing environment and commercial segment of medical devices.
- Exposure to various PLMs and commonly used tools in medical device industry.
- Astute technical document authoring capabilities.
- Excellent Quality Assurance skills.

Client : Confidential