- ManpowerGroup (Wayne, NJ)
- …Development and Engineering team. This critical role ensures the quality and compliance of medical devices throughout the product development lifecycle. You will ... teams to identify risks, implement quality controls, and ensure compliance with industry regulations and standards. **What You'll Be...follow Design Control procedures and regulatory standards (ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR).… more
- Actalent (Princeton, NJ)
- …management of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving ... + Collaborate with regulatory teams for submissions, amendments, and compliance -related documentation. + Address protocol deviations, audit findings, and inspection… 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
- Bristol Myers Squibb (Summit, NJ)
- …Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards. + Independent ownership of all lifecycle ... being met. + Ensure equipment, facilities and programs are maintained in compliance . **Knowledge & Skills:** + Excellent understanding of cGXP requirements and good… more
- Bristol Myers Squibb (Summit, NJ)
- …plans for hazardous materials, potent compounds, and high-containment processes. + Ensure compliance with OSHA, ACGIH, NIOSH, FDA , and other applicable health ... is critical in ensuring workplace safety, employee health protection, and compliance with regulatory standards. The ideal candidate will have comprehensive… more
- Sumitomo Pharma (Trenton, NJ)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional… more
- System One (Florham Park, NJ)
- …in development (including 2 new IND applications and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances + Performance will be monitored via ... degree preferred. + 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred. +… more
- United Therapeutics (Trenton, NJ)
- …are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public ... a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …industry organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. ... officials. Ability to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company objectives. Ability to… more
- Sokol Materials & Services (Skillman, NJ)
- …degree is preferred. + Minimum of 7 years of CQV experience in pharmaceutical , biotechnology, cell therapy, or medical device industries, with at least 5 years ... Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: +… more