- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic ... more years data management and/or related industry work experience in a medical device , pharmaceutical company, or similar environment (eg, CRO)… 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
- Nesco Resource (New Haven, CT)
- …safety, performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.gIEC 62366, ISO 11608 series, ISO ... You will need to have: Experience in commercialization of medical device and/or combination products Deep knowledge... and/or combination products Deep knowledge of regulatory and compliance requirements for device risk management 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … development and/or post marketing in clinical research, pharmaceutical, CRO or medical device setting required- Experience within oncology therapeutic area ... 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)
- … development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting preferred- 4 or More Years Experience in oncology ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- BioAgilytix (Durham, NC)
- …for Medical Devices, ISO 13485, FDA and (New) EU Medical Device requirementsCE Mark product certifications experienceDemonstrated project coordination and ... fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety… more
- Catalent (Manassas, VA)
- …experience , required Experience working in an auditing role within the Pharmaceutical/ Medical Device industry Knowledge and understanding of the following ... Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. As… more
- Catalent (St. Petersburg, FL)
- …years auditing experience Experience working in an auditing role within the Pharmaceutical/ Medical Device industry, required Knowledge and understanding of the ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. The… 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
- 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)
- …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
- Medline Industries LP (Hartland, WI)
- …Work Experience At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk ... At least 2 years of supervisory/managerial experience preferred. Experience in Medical Device , Pharmaceutical, Food, Cosmetic, or Personal Products Industries… more
- Valmont Industries, Inc. (Tampa, FL)
- …workforce. Are you ready to move the world forward? Apply now.Essential FunctionsMaintain compliance with FMCSR hours of service (HOS) described in Part 395 of the ... FMCSR, using OmniTracs HOS Electronic Logging Device (ELD) module.As necessary, assist with loading and unloading...Avoids waste of time and materials.Submits to required DOT drug and alcohol testing regulations as described in Part… 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
- 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
