Product Regulatory Engineer
HCL America Inc.
Franklin Lakes , NJ 07417
Posted 3 months ago
Keywords: Quality Engineer, MDD, MDR regulations, medical device exp.
Surgical disposables, FDA QSR, 21CFR Part 820- Quality System regulation
ISO 13485 / FDA Guidelines
Knowledge on standards and regulatory requirements for various regionsResponsibilities:
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 understanding 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.
Medical Domain, MDD, MDR, Regulatory, Surgical disposables