- Fujifilm (Columbus, OH)
- …Keep abreast of new legislation and enforcement matters relevant to the medical device industry as well as industry and compliance best practices. + Perform ... + Bachelor's Degree. + 2 to 3 years of corporate compliance experience in the medical device and/or pharmaceutical industry and working knowledge of… more
- Arrow Electronics (Burlingame, CA)
- …Collaborate with XFN teams, including software and hardware engineers, product managers, and medical device compliance , to design and implement secure ... Meta Security Teams + Collaborate with the legal, SWE, program management, and medical device compliance teams to ensure that our products comply with… more
- Nissha Medical Technologies (Buffalo, NY)
- …anyone looking to have a career in Regulatory, Quality and has an interest in Medical Device regulatory compliance . You will focus on becoming familiar with ... international Medical Device Regulatory compliance requirements, with a special focus on RA Compliance data collection activities for Buy & Resale… more
- 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, ... your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide… more
- Takeda Pharmaceuticals (Boston, MA)
- …Device Quality, PV Compliance etc. **ACCOUNTABILITIES:** + Ensure organizational compliance with relevant medical device legislations and regulations ... and/or working knowledge of the key compliance requirements of the EU Medical Device Regulation and the FDA Code of Federal Regulations for devices and other… more
- Organon & Co. (Jersey City, NJ)
- …Activities will include developing, documenting, and review of documentation to ensure compliance with applicable Medical Device Regulations and internal ... Organon requirements. Sr. Quality Engineer ( Medical Device /Combo Products) is responsible for program planning and execution of prospective or remediation… more
- Integra LifeSciences (Plainsboro, NJ)
- …and set new standards of care. The **Sr.** **Quality Engineer - Medical Device / Pharma** will provide Plant Quality compliance support for the following ... that ensure that the development, manufacture and distribution of medical products is in compliance with corporate...and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …years related work experience of skills/attributes listed below with medical device in Systems Engineering or Compliance Support (combination of work ... knowledge or Critical Parameter Management. + Knowledge of global medical device regulations + Performed regulatory compliance assessments for US and… more
- Kelly Services (Valencia, CA)
- …inspection readiness activities. * **Product Labeling:** Collaborate cross functionally to ensure compliance with global medical device labeling regulations ... compliance with all applicable regulations of active implantable medical devices. Your expertise will contribute to creating and...a cross-functional matrix environment. * 5+ years Class III Medical Device Company in Regulatory Affairs. *… more
- Medtronic (Memphis, TN)
- …and optimize SAP solutions tailored to the unique needs of life sciences and medical device companies, ensuring compliance , efficiency, and accuracy in ... for OTC in alignment with life sciences/ medical device industry standards, ensuring regulatory compliance . SALES...medical device industry standards, ensuring regulatory compliance . SALES & DISTRIBUTION (SD) MODULE + Configure and… more
- Stryker (Kalamazoo, MI)
- …(NC/CAPA). **Preferred:** + Experience in software technical support resolution within the medical device industry, ensuring compliance with regulatory ... 's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical... (SaMD) and Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance… more
- Medtronic (Northridge, CA)
- …the specifications, and in compliance , which includes Complaint analysis activities, Medical Device Reporting (MDR) and complaint handling to include FDA ... and two (2) years of experience as a Consumer Affairs Specialist, Medical Device Reporting Compliance Specialist or related occupation; or Bachelor's degree… more
- Motion Recruitment Partners (Lake Forest, CA)
- …Diego.** **Role Requirements:** 1. Minimum Education and Experience: BS + 4+ years in medical device products safety compliance , and/or fully accredited test ... knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance , and/or fully accredited test labs. **The… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Experience coordinating, prioritizing, setting timelines, and multi-tasking. + Expertise with medical device regulations and compliance guidelines for ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- Bayer (Whippany, NJ)
- …**Reference Code:** 842231 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Medical Device , Biomedical Engineering, Compliance , Regulatory ... a BS degree is required; + Expert knowledge of regional and global medical device regulations (eg, EU MDR, Declarations of Conformity, CE Marking, ISO 13485, FDA… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Solid understanding of secure firmware update protocols and architecture. + Experience with medical device compliance and documentation as per FDA and ... communicate clearly with team to document designs, review code, and ensure compliance with security and performance guidelines. Qualifications: + Essential: + Proven… more
- Fresenius Medical Center (Lawrence, MA)
- …development process, including specification, documentation, and quality assurance + Experience in medical device safety and EMC compliance (IEC 60601, ... REQUIRED SKILLS** + Minimum 7+ years' experience in electrical product development, medical device or highly regulated product development preferred. +… more
- AbbVie (North Chicago, IL)
- …ISO 13485). Responsibilities: + Perform QA activities related to Combination Product and Medical Device Development: + Ensure compliance with company ... Purpose: Responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements… more
- Integra LifeSciences (Princeton, NJ)
- …system (QMS) and associated controls meet regulatory and industry standards, ensuring full compliance with medical device regulations such as FDA, ISO, ... outcomes and set new standards of care. The Quality Compliance Manager for Management Controls will support the activities...years of experience required. Minimum 8 years experience in quality/ medical device industry. + Strong knowledge of… more
- Integra LifeSciences (Cincinnati, OH)
- …(direct reports or projects) or equivalent education and years of management experience in QA/ Compliance within Medical Device Industry. OR Master degree in ... team or equivalent education and years of management experience in QA/ Compliance within Medical Device Industry. + Extensive experience with development and… more
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