- AmerisourceBergen Drug Corporation (Conshohocken, PA)
- …will have three main responsibilities: 1) manage the overall vendor DSCSA compliance include authorized trading partner status and inbound TITHTS compliance ... as a primary point of contact with the Manufacturing Partners for all compliance processes including but limited to: exempt product maintenance, Unique Device … more
- Vera Therapeutics (Brisbane, CA)
- …from concept to commercialization. The ideal candidate will possess a deep understanding of drug delivery systems, medical device regulations, and a proven ... Title: Senior Manager, Drug Device Combination Product Development Location:...of successful product launches. Experience in the pharmaceutical or medical device industry preferred. * Extensive experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Monitors regulatory landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance + ... Responsible for demonstrating Takeda leadership behaviors + Serves as Drug - Device Combinations US lead for assigned asset...preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and meetings with global health authorities + Reviews and approves medical device development design control documentation, including technology transfer ... and enable CMC regulatory team's success in meeting goals/objectives on drug - device combination and allied filings **ACCOUNTABILITIES:** + Responsible for… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department. This position is a Corporate Quality function ... bridge between departments, CMOs and sites respective to Combination Drug Products and Medical Devices. This position...dynamic, high paced and highly interdisciplinary environment to support Drug Device Combination Products. The role will… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . Employer: Bristol-Myers Squibb Company Position: Sr. Manager, Medical Device Safety (Ref: 4185) Location: 3551 Lawrenceville ... for medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, 21CFR 803,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …engineering discipline (advanced degree preferred) + 8+ years of biotechnology, pharmaceutical or medical device industry experience + 5+ years of regulatory ... pertaining to the development, registration, commercialization and lifecycle management of the medical , ancillary, or combination device in the United States and… more
- University of Michigan (Ann Arbor, MI)
- …performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and ... Cardiac Device Technician Apply Now **How to Apply** A...summarized as a report for entry to the electronic medical record ensuring physician evaluation with appropriate billing. The… more
- Merck (Rahway, NJ)
- …advanced degree (Master's or PhD) preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a ... + Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and… more
- ICU Medical (CA)
- *Position Summary*// The Device Sales Specialist is responsible for meeting and exceeding an annual sales quota through building and maintaining relationships with ... ICUMedical Infusion Systems portfolio (Plum360, CADD, Medfusion, MedNet and Pharmguard drug error reduction software system (DERS), IV EHR, plus Temperature… more
- AbbVie (North Chicago, IL)
- …with 6+ years of experience (MS preferred) + Experience must include significant device development, with medical device , pharmaceutical or other regulated ... individual will contribute to the development of exciting new drug / device combination products for various phases of...practice of Design Controls (CFR 820.30 / ISO 13485), Medical Device Software Lifecycle (ISO 62304), and… more
- Sandia National Laboratories (Albuquerque, NM)
- …Requirements for MedPEDs: If you have a Medical Portable Electronic Device (MedPED), such as a pacemaker, defibrillator, drug -releasing pump, hearing aids, ... of onsite work and working from home) + Generous vacations, strong medical and other benefits, competitive 401k, learning opportunities, relocation assistance and… more
- National Renewable Energy Laboratory (Golden, CO)
- **Posting Title** Postdoctoral Researcher - Fuel Cell, Electrolysis, CO2 Reduction Device Performance and Durability . **Location** CO - Golden . **Position Type** ... internal pay alignment when determining the salary level for potential new employees. In compliance with the Colorado Equal Pay for Equal Work Act, a potential new… more
- HonorHealth (Scottsdale, AZ)
- …to learn more. HonorHealth is looking for an RN Ventricular Assist Device (VAD) Clinical Manager to support our new, inviting and exciting Program. ... area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer… more
- Stryker (Minnetonka, MN)
- …+ Participate in on-call rotation schedule - required Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, ... availability of requested products + Compile and inspect incoming/outgoing kits for compliance with specifications and usage + Clean and maintain supplies, tools,… more
- Stryker (Hanover, MD)
- …experience in a demanding and fast-paced environment Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, ... availability of requested products. + Compile and inspect incoming/outgoing kits for compliance with specifications and usage. + Clean and maintain supplies, tools,… more
- AbbVie (Irvine, CA)
- …to travel 5-10% of the time Join our team and contribute to groundbreaking medical device development in support of AbbVie's diversified pipeline. Apply now to ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...and coordinating the ideation, assessment, and development of novel drug delivery technologies as part of AbbVie's Combination Products… more
- Abbott (San Diego, CA)
- …and work experience. + Minimum 10 years progressively work experience in medical device or high technology industries. Roles of increasing responsibility, ... direct supervisor experience. + Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic. + Knowledge… more
- AbbVie (North Chicago, IL)
- …to release to market is desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...individual will contribute to the development of exciting new drug / device combination products for various… more
- Integra LifeSciences (Mansfield, MA)
- …corporate policies, US Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device ... of management experience + Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation… more
