- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …bring new and modified medical devices to market and ensure ongoing compliance . They participate on cross-functional teams, lead the development of global regulatory ... in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other regulatory documents for submission to… more
- Kedplasma (Cinnaminson, NJ)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more
- Integra LifeSciences (Plainsboro, NJ)
- …Quality Operations (Validations, Risk Management & Statistics)** will provide Plant Quality compliance support for the following Quality tasks and duties: Assist in ... that the development, manufacture and distribution of medical products is in compliance with corporate policies, US Food and Drug Administration regulations, ISO… more
- Integra LifeSciences (Plainsboro, NJ)
- …processes as per outlined production schedules. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing ... all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the… more
- Vitalief (New Brunswick, NJ)
- …whether each trial is a qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines. + ... billing administrative start-up, insuring clinical research billing and regulatory compliance . Collaborate with Finance to coordinate documentation of each clinical… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …concept development, product verification, and validation, legal and regulatory compliance , demonstration of product value, and stakeholder education. In addition, ... Standard Operating Procedures to optimize MA functioning in terms of leadership, compliance and productivity. The Director, Medical Affairs, will assist the VP,… more
- Integra LifeSciences (Plainsboro, NJ)
- …as per outlined production schedules. All production is to be conducted in compliance with ISO 7 Clean Rooms and with Good Manufacturing Practices (GMP), Quality ... all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the… more
- Wise Foods, Inc. (Totowa, NJ)
- …Develop and execute annual/quarterly service key performance indicators and objectives. Compliance Duties: + Evaluate and write up performance letters, track ... least a year. + Possess basic Knowledge of OSHA, FDA , EMP, FMLA, ADA. IDEAL CANDIDATES also have the...+ Has worked with certifications or audits from OSHA, FDA , EMP. + Has worked with FMLA and ADA… more
- Bayer (NJ)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... compliance guidelines for all external contacts; + Prepares and...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- Bristol Myers Squibb (Princeton, NJ)
- …risk management and compliance with local and international PV regulations (eg, FDA , EMA, ICH). + Oversee safety operations team members and vendors in managing ... experience + Experience with global pharmacovigilance regulations and guidelines, including FDA , EMA, and ICH + Demonstrable understanding of clinical development,… more