- Sanofi Group (Morristown, NJ)
- …+ In-depth knowledge of International pharmacovigilance requirements/ EU, FDA requirements/international guidelines, ICH/CIOMS, with experience in their practical ... application + In-depth understanding of pharmacovigilance processes, regulatory compliance and needs of standardization. Knowledge of GCP and validation of… more
- BioLife Plasma Services (Trenton, NJ)
- …and build your skills by contributing to financial, marketing, administrative, regulatory , quality, people, and facilities management. + **Contribute to Creating ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Integra LifeSciences (Plainsboro, NJ)
- …must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The ... + Change control, non-conformance and CAPA support. + Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. **QUALIFICATIONS**… more
- Integra LifeSciences (Plainsboro, NJ)
- …Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies. Experience with assessing quality suppliers and purchasing ... and standards, and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the CMC facility **DESIRED… more
- US Tech Solutions (Branchburg, NJ)
- …as critical care. **JOB SUMMARY:** * Responsible for maintaining compliance with FDA , AATB, international and state regulations during the second level quality ... suitability and distributed products, triggering escalation procedures and evaluation for regulatory action. **Education and Experience** NJ RN license from an… more
- Benco Dental (Edison, NJ)
- …- Own the enterprise security posture, ensuring adherence to all relevant regulatory frameworks (eg, HIPAA, PCI-DSS) and implementing a zero-trust approach. + IT ... + Familiarity with relevant regulations affecting healthcare-related supply chains (HIPAA, PCI-DSS, FDA UDI, or similar). + Strong financial acumen and the ability… more
- Kedplasma (Cinnaminson, NJ)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... operating supplies are available as needed. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. + Responsible for remaining… more
- Terumo Medical Corporation (Somerset, NJ)
- …to management on pricing, manufacturing, packaging, distribution, promotion, market research, regulatory , legal and any issue which impacts product responsibility. + ... new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. +… more
- Taiho Oncology (Princeton, NJ)
- …teams regarding communications strategy and planning. + Review and approve the regulatory content of materials created for product promotion, corporate, and other ... as strong collaborative/emotional intelligence skills required. + Current knowledge of FDA guidelines and regulations with an emphasis on promotional activities. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies. **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job ... + Author or revise Standard Operating Procedures (SOPs). + Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits. + Interpret… more