- 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
- Abbott (Plymouth, MN)
- …reports) to achieve departmental and organizational objectives. + Review applicability of International medical device regulations to ensure submission ... also have access to: + Career development with an international company where you can grow the career you...working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that… 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
- Abbott (Plymouth, MN)
- …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... US device regulations and/or experience with EU and other international medical device regulations and submissions. + Experience with risk management,… 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 (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
- 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
- Eurofins (Boston, MA)
- …building a strategic vision and team to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality ... Eurofins Scientific is an international life sciences company, providing a unique range...organization as a leader in consulting services for the medical device testing industry. + Define and… 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
- Lilly (Indianapolis, IN)
- …5+ years of experience with materials engineering in highly regulated industry ( medical device engineering preferred) + Knowledge of polymer materials chemistry, ... agendas for Lilly devices and for providing technical support to global device manufacturing operations with interface to functional groups inside and outside IDM.… more
- Mallinckrodt Pharmaceuticals (Madison, WI)
- … Device Engineering to join our senior leadership team at our Madison, WI medical device manufacturing site. This key role is central to driving engineering ... and efficiency. You will play a crucial part in shaping the future of medical device engineering, ensuring regulatory compliance, and fostering a culture of… more
- Sanofi Group (Morristown, NJ)
- …was possible. Ready to get started? **Our Team:** The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... commercial development programs. You will be responsible for concept development of innovative medical device technologies, from ideation to proof of concept, in… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Sr. Manager, Medical Device Quality Systems, is responsible for supporting the ... expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory compliance… more
- Geisinger (Danville, PA)
- …preparing reports for physician evaluation and approval for entry to the medical record. Troubleshoot critical device issues and take immediate steps ... Assists with the day-to-day function of the outpatient Electrophysiology (EP) Heart Rhythm Device Clinic (HRDC). This specialist will collaborate with the Device … more