- Bristol Myers Squibb (Princeton, NJ)
- …program. Including specialized training for Cyclotron operators and radiochemists, x-ray device users, preclinical imaging, radiochemistry suite, medical staff, ... NJDEP. + Serve as the Cyclotron Particle Accelerator Safety Officer (PASO). Regulatory qualifications/requirements to be eligible as a PASO are noted in… more
- Integra LifeSciences (Plainsboro, NJ)
- …a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and ... a Validation or Quality Assurance role for a medical device or pharmaceutical environment. + Demonstrates excellent organizational and communication skills.… more
- Integra LifeSciences (Plainsboro, NJ)
- …timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As ... degree or equivalent with 5+ years of experience + Experience in the medical device , pharmaceutical or similarly regulated industry with experience in process… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management ... Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care...Escalates to senior leadership as needed . Partners with Quality Assurance to resolve quality -related issues with… more
- IQVIA (New Providence, NJ)
- …is a fast-growing business focused on delivering fit for purpose solutions to the medical device and in vitro diagnostics industry. As a **Mid-Market Key Account ... account management experience** and/or solution sales management experience (required). + ** Medical Device / MedTech Industry experience required.** +… more
- System One (Mahwah, NJ)
- …Engineer Location: Mahwah, NJ Compensation: $53.00- $70.00 Type: Contract Overview Global Medical Device company looking for experienced Engineer to join their ... up to and including that necessary to support a regulatory submission. Requirements + A minimum of BS degree...analysis and familiarity with Minitab and/or MS Excel. + Medical device or similar regulated industry experience… more
- Integra LifeSciences (Princeton, NJ)
- …and Operations to ensure alignment across product lifecycle phases and compliance with medical device regulations (eg, FDA, ISO 13485, MDR). Ensure supplier ... execute plans. + Deep knowledge of global sourcing, contract manufacturing, and regulatory compliance in medical devices. + Strong leadership, negotiation, and… more
- J&J Family of Companies (New Brunswick, NJ)
- …meta-analyses + Evaluate the relevance and reliability of new data sources for medical device studies, including product-specific studies of J&J devices + ... and epidemiologic research to support post-market safety and effectiveness, regulatory submissions, product development, product launches, value assessments, predictive… more
- Merck (Rahway, NJ)
- …: Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device , Packaging, and Analytical, Regulatory , Quality , and Supply ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
- Sokol Materials & Services (Skillman, NJ)
- …experience in CQV and/or CSV within the pharmaceutical, biotechnology, cell therapy or medical device industries. + Experience with Cell Therapy equipment (cell ... guidelines, industry trends, and best practices related to validation and quality assurance. Industry Awareness: Stay up-to-date with regulatory guidelines,… more