- Chemours (Trenton, NJ)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Fujifilm (Trenton, NJ)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards. This critical...regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory… more
- Merck (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design,...Product Working Groups to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Merck (Rahway, NJ)
- …**Job description** This position will be responsible for leading and implementing medical device and combination product design controls for both new ... Development and with external suppliers. + Understand and apply regulatory / compliance requirements relative to design...years of related experience + Has broad knowledge of medical device development, design controls and risk… more
- Integra LifeSciences (Plainsboro, NJ)
- …and set new standards of care. The **Sr.** **Quality Engineer - Medical Device / Pharma** will provide Plant Quality compliance support for the following ... that ensure that the development, manufacture and distribution of medical products is in compliance with corporate... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory … more
- J&J Family of Companies (Raritan, NJ)
- …to integral and non-integral medical devices, in vitro diagnostics, and software-as-a- medical device . + analyzing safety responsibilities for each device ... CFR Part 4, and ISO 13485/14971/20916. Within this hybrid regulatory and compliance framework, the DSA is... device safety, or biomedical/systems engineering (with demonstrated medical device experience) is required + Ability… more
- Merck (Rahway, NJ)
- …Reporting to the Director responsible for this area, you will partake in medical device assembly and process development using semi-automated and automated ... needed. **Key Responsibilities:** + Experience with, and a fundamental understanding of medical device assembly equipment to enable development of product… more
- Astrix Technology (Essex County, NJ)
- **Sr Staff Scientist - Medical Device ** Science & Research Essex County, NJ, US Pay Rate Low: 128000 | Pay Rate High: 184000 + Added - 27/05/2025 Apply for Job ... _Our client, a world-leading medical device company focused on improving lives...initiatives across product development, method validation, risk assessment, and regulatory compliance . **Key Responsibilities:** + Lead the… more
- RWJBarnabas Health (Newark, NJ)
- …leadership, and staff training. + Comprehensive knowledge of CMS guidelines, regulatory compliance , and VAD technologies. Qualifications: Required: + Bachelor's ... clinical leadership, and staff training. + Comprehensive knowledge of CMS guidelines, regulatory compliance , and VAD technologies. Preferred: + Master's Degree… more