- Integra LifeSciences (Princeton, NJ)
- …mindset, a willingness to learn about bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring ... a focus on bacterial endotoxin testing programs in the medical device industry. The successful candidate will...ANSI/AAMI ST72, ISO 11737-3, USP <85>, USP <161>, and FDA guidelines. + Ensure proper integration of endotoxin testing… more
- Fujifilm (Trenton, NJ)
- …and advertising regulations and other regulations specific to Life Sciences/Pharma and Medical Device companies. + Perform other duties as assigned. **Required ... corporate law firm and/or in-house legal department, preferably in the Life Sciences/Pharma, Medical Device or health care field. + Solid commercial contract… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Actalent (Basking Ridge, NJ)
- …Microsoft Office programs (Word, Excel, PowerPoint, Outlook). + Knowledge of global medical device labeling requirements. Additional Skills & Qualifications + ... Job Title: Quality Associate Job Description The Quality ...Ability to take and follow directions. + Familiarity with FDA Labeling guidelines (21 CFR). + Excellent communication and… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and other international requirements and submissions. + Knowledge of product development and medical device quality system regulations. + Experience with ... and other global regulatory requirements are met. + Evaluates medical device regulations and leads development of...US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other regulatory documents… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Integra LifeSciences (Plainsboro, NJ)
- …overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... outcomes and set new standards of care. SUMMARY DESCRIPTIONThe ** Quality Inspector I** will be responsible for performing ...clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. + QA experience in… more
- Integra LifeSciences (Princeton, NJ)
- …experience is required. + Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation ... Experience in implementing remediation programs, and working with compliance frameworks such as FDA , ISO 13485, and EU MDR is required + Strong analytical skills,… more
- J&J Family of Companies (Raritan, NJ)
- …device industry + Good working knowledge and understanding of medical device regulations, standards, and regulatory bodies, eg FDA (Food and Drug ... other SOPs, balancing flexibility, efficiency, and speed, while adhering to applicable medical device industry regulations. This person will represent R&D for… more