- Sanofi Group (Cambridge, MA)
- …Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA) + Good knowledge of medical device regulations and international standards, eg: ISO 13485, 21 ... Software Quality Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as… more
- 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 (Santa Clara, CA)
- …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements ... also have access to: + Career development with an international company where you can grow the career you...**The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program**… 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
- Meta (Washington, DC)
- …compliance and business units, with a focus on fraud & abuse, medical device compliance, FDA and analogous international compliance issues in the medical ... an experienced attorney to serve as Associate General Counsel for Healthcare and Medical Device Compliance on Facebook's Corporate Compliance & Ethics team. This… 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
- Corza Medical (San Diego, CA)
- …event reporting. + Understanding of risk management as it pertains to the lifecycle of a medical device . + Domestic or International up to 10% of the time. ... of experience is Post Market Surveillance areas and processes in Medical Device or regulated environments. + Proven record implementing and maintaining complaint… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …Ability to independently perform work of a broad nature. + Extensive knowledge of medical device regulations, industry or international standards and ability ... leadership techniques and project management methodologies. + Broad knowledge of medical device / pharma manufacturing processes. + Excellent communication… 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
- LSI Solutions (Victor, NY)
- …lines, helping to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) ... requested by distributors, with direction. + Communicates with distributors for ROW medical device registration, with direction. + Maintains the ROW Regulatory… 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
- Nissha Medical Technologies (Buffalo, NY)
- … Device regulatory compliance. You will focus on becoming familiar with international Medical Device Regulatory compliance requirements, with a special ... be able to learn about the responsibilities of a Regulatory Department within a global Medical Device Business. This is a great opportunity for anyone looking to… more
- Abbott (Plymouth, MN)
- …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 (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 (Irving, TX)
- …years of related experience. **Preferred Qualifications** + Manufacturing engineering experience. Medical device experience preferred. + International ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Integra LifeSciences (Princeton, NJ)
- …teams, marketing teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA ... Supplements,361 HCT/Ps, and international dossier submissions; Experience with medical device , biologic or implantable products is preferred, but not… 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 (Pleasanton, CA)
- …PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions. + Ability to work ... US, EU (EU MDR), and other international geographies. + Experience with medical device software requirements and software regulations. + Ability to identify… more
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