• Program Manager - EU…

    Medtronic (Mounds View, MN)
    …Surgical product portfolio achieves initial European Union Medical Device Regulation ( EU MDR ) and UK Conformity Assessed (UKCA). This Program Manager ... of interdependent information to create recommendations for action and program success. + Cultivate a broad understanding of Medtronic's...+ PMP or PgMP certification + Strong knowledge of EU MDR and UKCA regulations + Experience… more
    Medtronic (07/24/25)
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  • Manager , Complaint Handling

    J&J Family of Companies (Danvers, MA)
    …: + Oversee global complaint processing in compliance with FDA, Health Canada and EU MDR Quality System Regulations and country specific vigilance regulations. + ... CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR , EU MDR and country specific vigilance related… more
    J&J Family of Companies (07/25/25)
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  • Program Manager

    Actalent (Irvine, CA)
    Job Title: Program Manager For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.comwith the ... products, specifically focusing on venous thromboembolism clot removal. The Program Manager will be accountable for all...conduct spot checks to maintain quality standards. + Manage EU MDR Plus or base business or… more
    Actalent (07/23/25)
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  • Manager , Regulatory Affairs Medical…

    Bausch Health (Bothell, WA)
    …+ Regulatory affairs professionals responsible to complete 510(K), Health Canada, EU MDD/ MDR Technical Documentations, STEDs for global registration purpose ... and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible...APAC is a plus. Experience on 510(K), Health Canada, EU MDD/ MDR Technical Documentations, STEDs for global… more
    Bausch Health (07/09/25)
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  • Regulatory Affairs Manager - Heart Failure…

    Abbott (Pleasanton, CA)
    …a supervisory/managerial level. + Strong working knowledge of regulatory requirements for US, EU ( EU MDR ), and other international geographies. + Experience ... (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU… more
    Abbott (06/16/25)
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  • Manager , Regulatory Affairs-Medical…

    Bausch Health (Bothell, WA)
    …authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above). + Please ... and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations...helping with submissions in regions such as the US, EU , Canada, or Asia. + Work with international teams… more
    Bausch Health (07/10/25)
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  • Principal Software and Security Compliance Audit…

    Medtronic (Minneapolis, MN)
    …+ Experience in Quality/Compliance and/or Audit with medical device requirements (eg, MDSAP, EU MDR , ISO 13485). + Experience with cybersecurity requirements. + ... TUV; EU MDR / MDCG. + IMDRF's Principles...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
    Medtronic (07/29/25)
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  • Program Manager

    Actalent (Irvine, CA)
    Job Title: Program ManagerJob Description As a Program Manager , you will lead projects focused on implementing manufacturing strategies for innovative ... + PMP certification or equivalent preferred. + Experience with EU MDR , labeling, and regulatory affairs. Additional...and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this… more
    Actalent (07/26/25)
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  • Quality Engineering Manager , Post-Market…

    Medtronic (Lafayette, CO)
    …and writing for compliance. * Knowledge and expertise in FDA 21 CFR 820 & 806, EU MDR (Regulation ( EU ) 2017/745), ISO 14971, ISO 24971, IEC 60812, and ... world. A Day in the Life of a Post-Market Risk, Quality Engineering Manager - reporting to Director of Post-Market Risk, Surgical Operating Unit. Responsibilities… more
    Medtronic (07/02/25)
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  • Program Manager I, Quality…

    Integra LifeSciences (Princeton, NJ)
    …remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR is required + Strong analytical skills, exceptional writing and ... project plan; + Reporting on the sites' progress to the ECMP Project Manager ; + Being responsible for the site(s) ECMP documentation and schedule; + Coordinating… more
    Integra LifeSciences (06/06/25)
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