- Novo Nordisk Inc. (Plainsboro, NJ)
- …Experience Level: 7+ years of relevant experience Minimum of 5 years clinical/ regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO ... Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.… more
- Medline Industries LP (Northfield, IL)
- …regulatory science, or related. Work Experience At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or ... international markets. Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files. Experience preparing responses and… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- … Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. Ensure site readiness for regulatory agency inspections and/or ... EU MDR (2017/745), CMDR (SOR/98-282).Experience in leading and/or supporting medical device regulatory inspections by...and approve device history records related to medical devices .Strong knowledge of handling of … more
- Merck & Co. (North Wales, PA)
- …related discipline, with minimum of 10 years of relevant experience in diagnostics and/or medical devices , the majority of which must be in diagnostic ... regulations on the development and registration activities for the respective medical products.-Providing regulatory support for due diligence activities, as… more
- Merck & Co. (Rahway, NJ)
- …including regulatory submission and approval processes.Has broad knowledge of medical device development, design controls and risk managementKnowledge of US ... of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and... Working Group to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …and payers. Discuss operational issues and reviews records/documentation to ensure regulatory and in-house compliance. Assists with Device Clinic research ... providing reports for the EP Physicians and the patient medical record. Participates in clinical research as job requires....on the job training and demonstrated proficiency in Cardiac Device Management may be substituted for the formal education… more
- Nesco Resource (New Haven, CT)
- …You will need to have: Experience in commercialization of medical device and/or combination products Deep knowledge of regulatory and compliance requirements ... to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms... regulatory compliance (EU and FDA) requirements of medical device and combination products (e.gIEC 62366,… more
- Careerbuilder-US (New Haven, CT)
- …HAVEN. PARKING WILL BE REIMBURSED You will be responsible for: . Manage medical device test method and specification development, including test method ... application of validation processes (IQ/OQ/PQ). . Interface with the medical device vendor and tooling company .... vendor and tooling company . Knowledge of the regulatory and compliance requirements of device design… more
- Nesco Resource (New Haven, CT)
- …products and assist the technology transfer.You will be responsible for: Manage medical device test method and specification development, including test method ... as application of validation processes (IQ/OQ/PQ). Interface with the medical device vendor and tooling company Knowledge...device vendor and tooling company Knowledge of the regulatory and compliance requirements of device design… more
- Nesco Resource (Rochester, NY)
- …facility, documentation is key to this position in order to meet regulatory requirements; therefore, the candidate must have experience in or an understanding ... of cGMPs and documentation in a regulated industry.Candidate must have a proven track record of planning and organization of daily workload, high affinity toward teamwork, and demonstrated problem-solving using innovative solutions.Having a working knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and devices .Provide strategic input on ... of IDE submissions and approvalsExtensive experience developing companion diagnostics and devices .Experience of drug development and drug regulatory procedures.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including therapy area marketing teams, portfolio strategy/BD&L, analytics, legal, regulatory , technology/IT, medical , R&D and global commercial strategy/digital ... holistic approach to digital health, incorporating aspects such as data, devices , diagnostics and digital solutions Opportunity Identification: Identify key digital… more
- Merck & Co. (Rahway, NJ)
- … activities with cross- product or cross-functional impact, including drug device /combination products and software-as- medical device platforms.- Reviews ... Job DescriptionThe Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical, life sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI ... Preferred Experience: Product management experience with regulated Software as a Medical Device (SaMD), and/or Digital Pathology Experience commercializing and… more
- Merck & Co. (North Wales, PA)
- …and the regulatory strategy of digital health tools (DHTs) and software medical devices (SaMD). In the preclinical space, RDH partners with functional ... regulatory requirements landscape for Drugs, Digital Health Technologies, and/or Medical Devices for both new product development for initial registration… more
- Arthrex (Ave Maria, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...actively searching for an Engineer I Quality Systems and Regulatory Compliance for our Ave Maria, FL Manufacturing Site.… more
- US Tech Solutions, Inc. (Austin, TX)
- …industry or in a clinical setting is preferred . Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. ... Individual will work in Client's global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.… more
- DivIHN Integration Inc (Green Oaks, IL)
- …study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices . May require an advanced degree and 5-8 years of ... 847 1027 Divya at 224 369 2969 Title: Specialist Regulatory Affairs, EURI/ MENAP Location: Abbott Park, IL Duration:...in the field. Recent experience with Class III implantable medical devices ; Proven successful track record of… more
- Medline Industries LP (Northfield, IL)
- …FDA/EU MDR requirements and experience with regulatory interactions as part of medical device regulatory approval process. Skill and ability to diagnose, ... new medical products with requirement knowledge of Class I-II medical devices , design controls, risk assessment and the 510k process. Experience applying… more
- Arthrex (Goleta, CA)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...for support and development of Class I and II medical devices , which includes, production support, service… more
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