- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Terumo Aortic (Sunrise, FL)
- …field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct experience ... in medical device regulatory affairs if...in medical device regulatory affairs if no degree. +...and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record… more
- ITG Brands (Greensboro, NC)
- …US jurisdiction. + Minimum of 10 years of legal experience, in a highly regulatory industry (tobacco, pharmaceuticals, medical devices ). + Strong background ... Senior Regulatory Counsel **Location** North Carolina **City** Greensboro **Role...**What We Offer** - Competitive benefits package that includes medical /dental/vision/life insurance/disability plans - Dollar for dollar 401k match… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of safety reports including ICSR electronic submissions, IND safety reports and Medical Device Reports, and aggregate reports Local Labelling Committee and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Terumo Medical Corporation (Somerset, NJ)
- …/clinical submissions, preferably as a medical writer for pharmaceutical, CRO, or medical device clients, a strong plus. **Nearest Major Market:** New Jersey ... and will develop and maintain core competence related to medical aspect of the devices produced and/or...documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, Key Opinion… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282). + Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, ... Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. + Ensure site...of Responsibility:** + Responsible as Management Representative, leading all regulatory inspections related to medical device… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …and audits. **Area of Responsibility:** + Participate in **FDA, ISO, and other regulatory inspections** related to medical devices and combination products. ... dermatology, ophthalmology and onco-dermatology. **Job Summary:** As a **QA Medical Device Specialist II** , you will...will support the QA Head in ensuring that all medical devices and combination productswhether manufactured in-house… more
- Merck & Co. (Rahway, NJ)
- …and design verification testing to developvalue-added solutions for medical devices and combination products.Build and enhance device or combination product ... Methodologies, Materials Engineering, Materials Science, Mechanical Engineering, Mechatronics, Medical Device Management, Medical Devices , Medical … more
- Merck & Co. (Rahway, NJ)
- …Moldings, Management Process, Manufacturing Compliance, Medical Devices , Product Commercialization, Quality Management System Improvement, Regulatory ... managing external partners in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on… more
- Merck & Co. (Rahway, NJ)
- …Inspection Readiness, Medical Device Management, Medical Device Manufacturing, Medical Devices , People Leadership, Personnel Recruitment, Process ... Job DescriptionRaw Materials & Medical Device Director, Small Molecule Analytical...this role, the Director of the Raw Materials and Medical Devices will lead a team of… more
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