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Regulatory Affairs Analyst
Location:
US-MA-Raynham
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<p class="wordsection1"><b>Role Regulatory Affairs Analyst</b></p> <p class="wordsection1"><b>Location</b> <b>Raynham, MA</b></p> <p class="wordsection1"><b>No of Vacancies 5 for West Chester, PA & 4 for Raynham, MA</b></p> <p class="wordsection1"> </p> <p class="wordsection1">JD </p> <p class="wordsection1"> </p> <ul> <li>Understanding of the concept of a product Technical Dossier or a Design dossier </li> <li>Experience with Regulatory and/or Quality documentation control and change control processes; </li> <li>Awareness of existence of regulatory requirements, regulatory approvals and importance of regulatory compliance </li> <li>Awareness of GMP concepts </li> <li>Experience with regulatory audits is a plus but not mandatory </li> <li>Able to operate Adaptiv system swiftly (conduct searches, extract information, create and manage COs, gathering approvals, creating ad hoc attachments, be able to follow the procedures); </li> <li>Knowledge on how to search and extract information from MDRiM system; </li> <li>Knowledge on how to manage products and licenses in MDRiM system is desired but not mandatory </li> <li>SAP and/or JDE skills are a plus, but not mandatory </li> <li>Experience with Johnson & Johnson is preferable</li> </ul> <p class="wordsection1"> </p> <p class="wordsection1"><b>Mandatory Skills</b></p> <ul> <li>A Bachelor's degree in Mechanical or Biomedical, with a minimum of 4 years of experience in the medical device industry or healthcare field is required</li> <li>Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports strongly preferred.</li> <li>Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.</li> <li style="margin-bottom:11px">Should have resource management skills to hold discussions with the stakeholders for sharing feedback and work with them for completion.</li> <li>Previous experience developing strategies to generate clinical evidence is strongly preferred.</li> <li>Must have ability to develop and maintain business partnerships at all levels of the organization.</li> <li>Expertise / proven record of working with onsite-offshore business model on mechanical engineering projects.</li> </ul> Adheres and comply to work instructions, Standard Operating Procedures

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