- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... BS with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least… more
- Merck (Rahway, NJ)
- …Materials Engineering, or similar **Experience** **8+ years of experience in medical device or combination product engineering.** **Demonstrated technical ... leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific… more
- Merck (Rahway, NJ)
- …Process, Manufacturing Compliance, Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance, Regulatory ... launch in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and...Minimum of 8 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with… 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 ... product launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, verification,… 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...consultants. + Ensure full compliance with design control standards, quality systems, and applicable regulatory requirements (eg,… more
- RWJBarnabas Health (Newark, NJ)
- …+ Conduct audits and reviews to ensure adherence to CMS guidelines and other regulatory requirements. + Collaborate with quality and compliance teams to address ... Director Patient Care Ventricular Assistive Device (VAD) ProgramReq #:0000189067 Category:Professional / Management Status:Full-Time Shift:Day Facility:Newark Beth… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …technical discipline required (eg, engineering, bioengineering, biology, chemistry). + Minimum 5 years Regulatory Affairs experience in medical device or in ... in negotiating with regulatory authority personnel (eg FDA, Notified Bodies) in medical device and in vitro diagnostic areas. **Knowledge and Skills:** +… more
- Integra LifeSciences (Princeton, NJ)
- …possess and demonstrate an understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Regulation, Canadian Medical Device Regulations, ... specialist position provides support across multiple functional areas, including regulatory intelligence, device establishment registration and listing (FURLS),… 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 ... EU, and other global regulatory requirements are met. + Evaluates medical device regulations and leads development of global regulatory strategies to… more