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Product Regulatory Engineer
Ref No.: 18-54483
Location: Franklin Lakes, New Jersey
Position Type:Direct Placement
Start Date: 07/31/2018

Mandatory Skills:

• Surgical disposables, FDA QSR, 21CFR Part 820- Quality System regulation
• ISO 13485 / FDA Guidelines
• Communication
• Knowledge on standards and regulatory requirements for various regions

Responsibilities:

• Experience in US FDA, EU, CFDA & International Regulations.
• 510 K Submission experience
• Hands on experience in Summary Technical documentation (STED) Documentation, PTR Updates
• Interpretation of medical / scientific information into RA technical document
• EU - MDD, MDR Regulations
• Minimum 4 Years' experience in ISO 13485, ISO 14971, 60601-1
• Sound knowledge of engineering first principles.
• Strong technical judgment and technical leadership skills.
• Experienced in Complete New product development process
• Design and development of plastic & rubber parts & product, preferably in a regulated industry
• Reasonable knowledge in Materials selection & processing techniques for plastic components.
• Strong project management, prioritizing and multi-tasking skills to work within tight deadlines.
• Deep undrastanding of Medical devices classifications (Regional and International regulations)
• Proactively define and assess regulatory risks associated with product development for assigned products.
• Works under general direction.
• Independently determines and develops approach to solutions.
• Contributes to a project of considerable significance or leads the projects.
• Supports RA through. Technical documentation, to support product registration, re-registration and renewal process.
• Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational and analytical methods.
• Ensures compliance with quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance principles.
• Provides advanced engineering skills and product evaluation support to the platform toward building business cases for new opportunities.