- ARUNDEL MACHINE (Emerson, NJ)
- …or reworks as needed + Ensure the company's products comply with all FDA regulations, prepare submissions and maintain regulatory databases + Adhere strictly ... to all CGMP, FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure the quality and integrity of the products and safety of the workplace + Keep Quality area organized and clean + Keep stock of Quality materials such as tip protectors, test… more
- Astrix Technology (Monmouth County, NJ)
- …evaluation and benefit-risk assessment reports + Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA , etc.), internal SOPs, and quality ... standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + Interpret and synthesize… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance. + Fills out decision trees when needed, after ... reviews and approves. + Generates MDR reports in accordance with BD procedures and FDA regulations. **To be successful in this role, you should be able to… more
- Bristol Myers Squibb (Princeton, NJ)
- …key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution ... optimize product benefit-risk profiles. The ED works cross-functionally with clinical, regulatory , medical affairs, quality, and commercial teams to support the safe… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, ... reports and for the preparation and approval of essential documents for regulatory filings. + Working with functional partners responsible for the clinical… 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, ... of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA , EMEA, TGA, ANVISA, and PMDA. + Knowledge of USP… more
- Merck (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products. The incumbent must be able to ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions. + Lead the… more
- Fujifilm (Trenton, NJ)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... in the development and structuring of new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.… more
- Kuehne+Nagel (Jersey City, NJ)
- …continuous improvement-aligning local execution with global company and client expectations. From FDA and EU GDP to internal Kuehne + Nagel protocols, you'll ensure ... building contractors and equipment suppliers helping each site maintain audit readiness, regulatory alignment, and a culture of quality. If you're passionate about… more
- System One (Monroe Township, NJ)
- …compliance with all relevant customs regulations.. Reporting into the Export Regulatory Manager, this role supports our business by managing documentation, tracking ... export compliance requirements, and assisting with audits and regulatory inspections. + Responsible for completing all required export regulatory documentation… more