- Merck & Co. (Rahway, NJ)
- …stability manufacturing by designing, developing, and scaling up the formulation, device , and manufacturing process. Driving drug product design from ... robust scientific methodology, we collaborate to discover and develop the next medical breakthrough. Our company's success is backed by ethical integrity, forward… more
- Insmed Incorporated (Bridgewater, NJ)
- …knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug , medical device and combination product manufacturing and ... In Plant (PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the quality assessment for… more
- Catalent (Harman, WV)
- …in a Scientific, Engineering or Biotech field within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality ... projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary ... GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.Participate in proactive functions that impact… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and ... quality deliverables on time and within budget to support drug development processes and global submissions. This position provides...of data management and/or related work experience in a medical device or pharmaceutical company, or similar… more
- Insmed Incorporated (Bridgewater, NJ)
- …Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical /Clinical Departments. The incumbent ... working groups to identify and mitigate GVP quality and compliance issues/risks. Provide support and training to other staff...prepare for inspections is required.Strong knowledge and understanding of drug and device FDA, EU and ICH… more
- Catalent (Philadelphia, PA)
- …is preferred.cGMP experience, Quality experience and/or experience working a pharmaceutical or medical device facility strongly preferred; exposure to FDA and/or ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,...initiatives Generous 401K match and Paid Time Off accrual Medical , dental and vision benefits effective day one of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- WuXi AppTec (Natick, MA)
- …long-term education and training for junior pathologistsResponsible for conducting toxicology and medical device studies in compliance with GLP/CNAS Perform ... limited to study evaluation for nonclinical studies spanning all phases of drug development for pharmaceutical industries. This position has the flexibility to be… more
- Fresenius Medical Center (Ogden, UT)
- …control activities. + Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical ... development and design changes and take accountability for quality compliance as a member of the cross-functional project team...+ Autonomy in decision making. + Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC,… more
- Catalent Pharma Solutions (Morrisville, NC)
- …Systems including document control, change control, and internal/external audits. + Ensure compliance to regulations for medical device and combination ... will also ensure all aspects of Design Controls for medical device /combination products are implemented and sustained....a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,… more
- Compass Group, North America (New York, NY)
- …Solutions, and Ambulatory EVS. Learn more at www.Crothall.com. Job Summary The Medical Device Integration and Cybersecurity specialist will be responsible for ... supporting Clients overall cybersecurity initiatives and Medical Device Integration (MDI). Utilizing Crothall's cybersecurity framework, technologies and… more
- Sutter Health (West Sacramento, CA)
- …in Northern California within the Sutter Health footprint. Responsible for Cyber Security, Medical Device Vulnerability, Medical Device Integration, and ... and practices. Primary functions include, data security definition and oversight, medical device cybersecurity management, remediation of identified security… more
- Organon & Co. (Plymouth Meeting, PA)
- …groups, Regulatory Affairs, Procurement and suppliers. Knowledge of design control, medical device , combination products, drug delivery, pharmaceuticals ... **Job Description** **The Position** The Senior Specialist Medical Device and Combination Product (MDCP)...and medical leave, and health benefits including medical , prescription drug , dental, and vision coverage… more
- Sanofi Group (Cambridge, MA)
- …Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as ... of Drug + apps. Our team has released an FDA certified class II medical device titration application. We are gearing up for other software applications across… more
- Lilly (Indianapolis, IN)
- …support communities through philanthropy and volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage ... + Review device surveillance processes, procedures, and/or report templates to ensure compliance with global device regulations. + Serve as a contact person… more
- Merck (West Point, PA)
- …medical devices and combination products globally. + Experience in design controls, device risk management, medical device , complex combination product ... are the cornerstone of decisions and expectations + Lead technical investigations of medical device and combination product needs for commercial products +… more
- Actalent (Foster City, CA)
- Medical Device Design Control Engineer to support onsite work in Foster City, CA. Description: * Act as a quality engineer for medical device QMS quality ... * Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR...and contract manufacturers to address and resolve complex technical drug - device combination product, process, and quality issues.… more
- Veterans Affairs, Veterans Health Administration (Minneapolis, MN)
- …EP Device nurse also serves as a resource for staff nurses, residents and medical students. The EP Device nurse is responsible for post procedure device ... Department and procedures. Serves as a resource for staff nurses, residents and medical students. Responsible for post procedure device implant education for… more
