Job Description :
Product Regulatory Engineer

Franklin Lakes, NJ

FTE



Keywords: Quality Engineer, MDD, MDR regulations, medical device exp.



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.