- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Provide mentorship, review and generate MDR reports utilizing BD procedures and FDA regulations. + Contribute to the business-wide quality strategy and ... in the complaint handling / trending, Medical Device industry, Medical Device Reporting, FDA regulations, GMP, Quality Systems and where applicable clinical and… more
- embecta (Parsippany, NJ)
- …and operations comply with internal standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance Auditor plays a strategic ... a culture of continuous improvement while driving adherence to quality and regulatory expectations across the organization....Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, ISO 14971, ISO 9001, MDSAP,… more
- Mondelez International (East Hanover, NJ)
- …adherence to internal quality standards (eg, OQS, SQE) and external regulatory requirements (eg, FDA ). + Review corrective and preventive actions (CAPAs) ... KPIs, and partner with cross-functional internal and external business partners (R&D, regulatory , marketing and manufacturing) to meet our quality agenda. In… more
- Sysco (Rahway, NJ)
- …improvement of an integrated QMS that meets ISO 22716 (Cosmetic GMP), FDA , EPA, and international regulatory standards. + Govern documentation systems, ... and product enhancement. + Ensure all products meet or exceed safety, quality , labeling, and regulatory requirements in domestic and international markets.… more
- Kuehne+Nagel (Jersey City, NJ)
- …building contractors and equipment suppliers helping each site maintain audit readiness, regulatory alignment, and a culture of quality . If you're passionate ... local execution with global company and client expectations. From FDA and EU GDP to internal Kuehne + Nagel...across regional sites * Support audits, inspections, complaints, and regulatory /customer interactions * Advise on quality strategy… more
- Merck (Rahway, NJ)
- …Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA , EMEA, TGA, HPB, ANVISA, ... contamination control. + Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA , EMEA, TGA,… more
- Innovation Foods LLC (Millville, NJ)
- …reporting to the General Manager, is tasked with leading all Food Safety, Regulatory , Sanitation, and Product Quality activities. The Director of Quality ... quality functions, with specific expertise in aseptic processing, regulatory compliance, and statistical process control. Supervisory Responsibilities: Direct… more
- Merck (Trenton, NJ)
- …outcomes to identify trends, drive improvements, and report findings to senior quality and management councils. + ** Regulatory Consultation:** Offers proactive ... PhRMA, and ISPE to stay at the forefront of regulatory and quality best practices. **Qualifications:** +...vaccines). + Deep expertise in GMP requirements across multiple regulatory agencies ( FDA , EU, ROW) + Strong… more
- Integra LifeSciences (Plainsboro, NJ)
- …Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO ... and set new standards of care. The **Sr. Q** **uality Engineer / Quality Operations (Validations, Risk Management & Statistics)** will provide Plant Quality … more