07/28/2016
Quality/Regulatory Associate
Medical Devices
NASP (North American Sterilization & Packaging) is a growing medical device company located in Franklin NJ. We are searching for a few key individuals to help build our organization. We offer Benefits with the position and compensation that is competitive and commensurate with skills and experience.
General Requirements
• Working regulatory knowledge in a manufacturing environment requiring adherence to government regulations and compliance with standards:
o FDA 21 CFR Part 820, and 13485/ 9001, etc.
• Ability to read and write technical documents.
• Detail oriented.
• Computer skills that include Microsoft Excel and Word.
• Self starter with the ability to multitask.
Responsibilities
• Administer various regulatory compliance functions, such as FDA, EPA, OSHA, and Medical Waste reporting,
• Administer Non-conformance program.
• Participate in internal audit program.
• Assist in external audits.
• Assist in trending and monitoring various parameters.
Qualifications
• Extreme attention to detail is critical, as is the ability to work independently
• Relevant work experience in the Medical Device field is highly preferred.
• Associates degree in a technical field and/or 3 years minimum experience in a regulatory environment is preferred.
Please submit resume to James Clifford- [email protected]
