- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Medical Device & Combination Product QA is responsible for quality and ... compliance oversight for late-stage development and new product introduction of medical device constituent part of combination products. Scope of… more
- Sanofi Group (Cambridge, MA)
- …Regulatory Affairs Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic ... **Job title: Device Regulatory Lead (Associate Director )** +...stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination… more
- Merck (Rahway, NJ)
- …controls and risk management + Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System ... above disciplines plus 5 years related experience + Experience with the development drug- device combination product or a medical device component of a… more
- Global Foundries (Malta, NY)
- …shape their markets. For more information, visit www.gf.com. Summary of Role: As the Director of Device Engineering, you will be a beacon of leadership, guiding ... is a leading full-service semiconductor foundry providing a unique combination of design, development, and fabrication services to some...our teams toward excellence in device performance and customer satisfaction. You will lead a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and contract manufacturers to address and resolve complex technical related drug device combination product, process and quality issues. + Ensure that ... and a Master's degree in a Science, Engineering or related field. + Medical device experience preferred + Demonstrates in-depth knowledge of Quality principles,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …company SOPs, all applicable laws, and regulations. Preferred Qualifications: + Experience with medical device /drug device combination products. + Proven ... Job Title Senior Director , Clinical Development & Medical Affairs...strategy and accountability for the nitric oxide drug and device program execution, ensuring alignment with brand team objectives,… more
- Abbott (Santa Clara, CA)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...MN currently has an on-site opportunity for an **Associate Director , Clinical Safety** professional. Reporting to the Global Safety… more
- System One (Lakewood, CO)
- …R&D, etc. QMS Compliance: + Demonstrates knowledge and skills of QMS/cGMP requirements including medical device and combination products. + Implements QMS to ... Title: Director of Product Quality Location: Littleton, Co Type:... industry + Demonstrated QMS and audit expertise for Medical Device and Combination products… more
- Medtronic (Lafayette, CO)
- … risk classes (US FDA classifications - Class I, II, III), Software as a Medical Device (SaMD), Combination Products, and/or HCT/P products. + Experience ... We are currently looking for a **Senior Quality Systems Director ** to join our Cranial and Spinal Technologies operating...day in the life as a senior leader in medical device quality systems can be quite… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and market trends, anticipating future needs and driving innovation in the medical device materials landscape. **People & Organization Development:** + Build ... the future of a broad, global portfolio of drug, device , combination products, where materials science innovation...translate scientific concepts into practical applications. + Passion for medical device innovation and a commitment to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …relation to manufacturing, packaging/labeling/serialization and distribution of small molecule and combination drug device products. + Accountable for product ... is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and...of clinical and commercial lots for small molecule and combination drug device . + Lead and manage… more
- University of Rochester (Rochester, NY)
- …Initiatives, continually modify, as necessary, current quality systems to comply with the Medical Device regulation (21 CFR Part 820) and the European Commission ... direct and oversee implementation and ongoing compliance with the Medical Device Regulations through the establishment of...(eg OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 &… more
- Abbott (Plano, TX)
- …single point of contact for prior authorization policy insights and implications to Abbott Medical Device portfolio strategy and may be required to design and ... executives, and scientists. **The Opportunity** We are recruiting a ** Director of Market Access** to serve as the **functional...Leaders, Health Strategies, ScotWork, etc. **Preferred** + MBA + Medical device or other pharma experience. +… more
- 3D Systems, Inc. (Littleton, CO)
- …through to final design transfer or technology transfer working primarily in medical device and industrial applications (such as aerospace, energy, ... Engineering Processes: o Remain current and proficient with US and international medical device and aerospace regulations. o Manage and improve product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening ... diseases. The Executive Director , Sterile Process Engineering and Packaging, will fulfill a...commercial devices, packaging, and fill/finish and assembly processes for combination products in the Gilead portfolio. The incumbent will… more
- Integra LifeSciences (Cincinnati, OH)
- …with corporate policies, US Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device ... in a scientific discipline required with min 15 years' experience in the medical device or pharmaceutical industry and minimum 10 years of people… more
- AbbVie (North Chicago, IL)
- … Device functionality (coordination of processing and US reporting of stand-alone medical device and combination product incident reports). . Proactively ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- University of Colorado (Aurora, CO)
- …requests and device compassionate use requests. + Assist the COMIRB Director to identify possible process improvement opportunities. + Assist the COMIRB ... COMIRB Assistant Director - 33731 University Staff **Description** **University of...- 33731 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Office of Regulatory Compliance - Colorado… more
- KPMG (Short Hills, NJ)
- …Minimum ten to fifteen years of Regulatory experience in the Medical device , consulting and/or business experience or combination thereof in the Quality ... **Business Title:** Director Life Sciences QMS **Requisition Number:** 113311 -...domain within the Life Science industry (Pharmaceutical, Medical Device , BioTech and Clinical Research Organization)… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory… more