• Sr. Regulatory Affairs Specialist

    Caldera Medical (Westlake Village, CA)
    …and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, ... event reporting, vigilance reporting, and corrective/preventive actions. * Ensure compliance with labeling, UDI (Unique Device Identification),...Medical is a growth stage medical device company dedicated to improving the quality … more
    Caldera Medical (08/24/25)
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  • Quality Systems Specialist

    AbbVie (Mettawa, IL)
    …regulations. Responsibilities + Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products. + ... quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. + Perform… more
    AbbVie (09/03/25)
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  • Quality Engineer I

    Olympus Corporation of the Americas (Redmond, WA)
    …+ Bioengineering, Mechanical Engineering, etc. with relevant educational experience for medical device industry preferred. Evidence of continued learning efforts ... Quality Engineer I is a role that provides Quality Engineering support to ensure compliance with...93/42/EEC Medical Devices Directive, SOR 98/282 Canadian Medical Device Regulations, ISO 13485, and any… more
    Olympus Corporation of the Americas (08/19/25)
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  • Senior Product Compliance Analyst

    Xylem (Chaska, MN)
    …and approval of risk activities as well as other deliverables as related to medical device projects * Review and approve all Labeling (product, advertising and ... Product Compliance Analyst** is focused on product compliance to regulatory requirements for medical devices...field, or equivalent work experience * 5+ years of Medical Device Regulatory Affairs experience, domestic and… more
    Xylem (07/09/25)
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  • Territory Manager- Shockwave (Manchester, NH)

    J&J Family of Companies (Manchester, NH)
    …professionally representing the company. + Comply with all corporate compliance , FDA, medical device , quality standards and ethics. + Other duties as ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
    J&J Family of Companies (09/04/25)
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  • Director, Quality

    3D Systems, Inc. (Littleton, CO)
    …Part 820) registration and inspection readiness. o Maintain ISO 13485, ISO 9001, MDSAP ( Medical Device Single Audit Program), Medical Device Regulation ... Quality , and Internal Audit Systems. * Ensure regulatory compliance . o FDA Quality System Regulation (21...Proven track record managing teams of individual contributors * Medical device and regulated industry expertise o… more
    3D Systems, Inc. (09/05/25)
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  • Senior Program Manager - Development Process…

    Medtronic (Northridge, CA)
    …Technical degree is a plus. + Experience with Design Control documentation within medical device industry or Pharma industry. + Experience conducting and ... of initiative and self-motivation. + Prior work experience in a regulated industry ( Medical Device Industry preferred) + Sound experience and through knowledge… more
    Medtronic (09/04/25)
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  • Quality Operations Engineering Analyst II

    Terumo Medical Corporation (Elkton, MD)
    …ID: 4771 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Systems & Compliance Terumo Medical Corporation (TMC) develops, ... manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
    Terumo Medical Corporation (07/09/25)
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  • Quality Engineer ( Medical Devices)

    Astrix Technology (Rahway, NJ)
    …+ 5% annual bonus eligibility Our client, a global leader in the medical device industry, is looking for a experienced Quality Engineer to join their growing ... ** Quality Engineer ( Medical Devices)** Engineering Rahway,...and standards. + Anager in the maintenance of the quality management system in compliance with appropriate… more
    Astrix Technology (08/28/25)
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  • Senior Quality Program Manager-Integrated…

    Philips (Latham, NY)
    …in full-cycle, global Quality Program/Project management within FDA regulated medical device Manufacturing /Supply Chain environments, with a focus on ... and support Kaizen, Hoshin's and daily management. + You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts… more
    Philips (08/29/25)
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