- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Lundbeck (Minneapolis, MN)
- …from an accredited college or university 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... major airport. Territory boundaries include: North Dakota excluding Williston, to International Falls, Duluth and northwestern Minneapolis down to the southwest… more
- Aequor (Thousand Oaks, CA)
- …development and commercialization or R&D in a life science, pharmaceutical, biotechnology, medical device cGMP environment. GMP environment work experience and ... Finance. This is a unique opportunity for top professionals to join our international organization, as a pioneer and leader in the development and commercialization… 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
- 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
- J&J Family of Companies (Horsham, PA)
- …Advanced statistical knowledge (eg multivariate data analysis) + Knowledge of local and international Medical Device regulations The anticipated base pay ... & Johnson, we all belong.** The MSO role is to provide medical safety stewardship for Medical Device (MD) products. Although a medically independent voice is… 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
- 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
- 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
- Olympus Corporation of the Americas (Center Valley, PA)
- … medical device customer relationship management, including domestic and international medical device regulations which include complaint handling, ... the service delivered meets expectations for quality, compliance, and international regulations. This includes adherence to FDA standards such...of experience in the business operation field and or medical device + Minimum of 10 years… more
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