Immucor, Inc. Sr. Manager Regulatory Affairs in Norcross, Georgia
Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics products that facilitate patient / donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for patients in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or a specific organ, as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together!
We are seeking to hire an experienced Sr. Manager of Regulatory Affairs to manage activities and provide leadership to staff associated with regulatory approval of IVD biological products and medical devices. Our ideal candidate will be responsible for activities which lead and maintain both domestic and international regulatory approval to market devices. Additionally, the Sr. Manager of Regulatory Affairs will be responsible for the assessment of product, facility and quality system changes for regulatory impact.
This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .
Participate with product development core teams as regulatory representative
Lead complex regulatory submissions
Provide regulatory support on project teams
Develop and track quality metrics for RA department
Review design, product, production, facility, utilities, promotional material, labeling, and software change orders for regulatory impact and domestic and international reporting requirements.
Develop regulatory strategies for implementation and provide regulatory requirements to assist with the development of regulatory strategies for product development and regulatory approvals.
Coordinate preparation, review and submission of product applications for new and current market authorizations: 510(k), BLA, Health Canada, CE mark and other foreign equivalents. Coordinate development of responses to deficiencies and/or questions related to regulatory submissions.
Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
Evaluate CAPA and complaint data to determine the need for medical event reporting, field action or biological product deviation reporting. Manage MDR and BPD reporting.
Manage, train, develop and supervise Regulatory staff.
Maintain regulatory product files.
Manage the creation and review of controlled documents and policy guidelines for the RA department.
Serve as an inspection coordinator during regulatory inspections.
Maintain departmental budget and other duties as assigned
Required Education and Experience
Bachelor's degree in Life Sciences or Medical Laboratory Science, or related area of study required
5 - 7 years' of experience in Medical Device Regulatory Affairs required, including product development, design controls and life-cycle management
Experience with CBER-regulated IVDs, Preferred
Experience in creating FDA 510(k) and BLA regulatory submissions, Health Canada License applications, technical files and design dossiers
Exceptional Interpersonal skills, demonstrated leadership abilities for leading people/teams
Competence in applying and assuring compliance to QSR, IVDR, Canadian as well as other current International Standards REQUIRED, including interfacing with Regulatory Authorities
Job ID 2018-1936