- US Tech Solutions (San Bruno, CA)
- …knowledge of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring product specifications are defined… more
- AbbVie (Pleasanton, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...work collaboratively with a team to design and develop medical products from initial concept through the transfer to… more
- AbbVie (Irvine, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …QSR, ISO 13485, MDSAP, and EU MDR/IVDR standards + Advanced knowledge of other international medical device regulations preferred (eg, China, Saudi, Korea, ... (Process, Test Method, Software, and Design) + Extensive knowledge of medical device regulations, industry or international standards and ability to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …QSR, ISO 13485, MDSAP, and EU MDR/IVDR standards + Advanced knowledge of other international medical device regulations preferred (eg, China, Saudi, Korea, ... (Process, Test Method, Software, and Design) + Extensive knowledge of medical device regulations, industry or international standards and ability to… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- … Coordination Group, Health Canada, Therapeutic Goods Administration (Australia), and the International Medical Device Regulators Forum (IMDRF). + Excellent ... risk management for the Olympus Digital Unit. + Develops threat models for medical device systems whose functionality is supported by Google Cloud Platform,… more
- Globus Medical, Inc. (Limerick, PA)
- …and procedures. Lead and enforce regulatory compliance with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system ... compliance with all regulatory requirements including US FDA, State, OSHA, and international medical device regulations based on ISO 13485 quality system… more
- Abbott (Sylmar, CA)
- …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. + Ability to work in a highly… more
- Abbott (Sylmar, CA)
- …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements ... PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. + Ability to work in a highly… more
- Abbott (Pleasanton, CA)
- …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements ... PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. + Ability to work in a highly… more
- Globus Medical, Inc. (NC)
- …with all company policies & procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system ... Service Engineer in a technical customer service/field service role; experience in the medical device industry preferred + Experience with GMP and ISO standards… more
- Abbott (St. Paul, MN)
- …Advanced degree + Experience with EU, Canada, Japan, China, Australia and other international medical device regulations and submissions + Experience ... also have access to: + Career development with an international company where you can grow the career you...acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory… more
- Medtronic (Lafayette, CO)
- …+ Design Dossier and/or Technical Documentation experience + Technical Writing + International medical device regulatory submission/approval experience, to ... Experience:** + Bachelors degree with 4+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry OR + An advanced degree… more
- Abbott (Pleasanton, CA)
- …PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions. + Must be familiar ... also have access to: + Career development with an international company where you can grow the career you...+ Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements… more
- Abbott (Santa Clara, CA)
- …development team. Provides guidance and expertise. + Maintains pertinent domestic and international medical device regulations to ensure submission ... + Class I, II, and/or III medical device experience + Monitors relevant US/ international regulatory requirements for medical devices including Quality… more
- Stryker (Orlando, FL)
- …Azure/Apple/Android etc.) + Thorough knowledge and understanding of US and International Medical Device Regulations (820/IEC 62304/IEC82304/60601) + ... our Medical 's Digital Health division and portfolio (Software as a Medical Device /Telehealth) to execute on Digital Health (Software as a Medical … more
- Abbott (Plymouth, MN)
- …+ Experience in the medical device industry. + Experience with international medical device regulations and submissions. + Familiarity with relevant ... position works out of our Plymouth, MN location, supporting our Electrophysiology medical device division. The **Senior Clinical Research Scientist** will lead… more
- Terumo Medical Corporation (Somerset, NJ)
- …and to identify customer complaints, as required by FDA, Canadian, European and International regulations related to medical device manufacturers and will ... is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and… more
- J&J Family of Companies (Columbus, OH)
- Director, Medical Affairs, Cardiac Medical Device - 2406216694W **Description** Johnson and Johnson Family is recruiting a **Director, Medical Affairs, ... pipeline, medical technology and competitors. + Maintain understanding of medical device development methodology, marketing and market access concepts,… more
- Geisinger (Danville, PA)
- Job Summary Provides leadership to the Heart Rhythm Device Clinic (HRDC) staff across the system. Provides direction to ensure effectiveness of roles and ... support and cooperation. Job Duties + Provides clinical leadership support to device clinic staff across the Heart and Vascular Institute. + Demonstrates physical… more