Sr. Specialist, Post Market Quality - Onsite (Urgent Need)

Responsibilities

• Performs Global Regulatory Impact Assessment (GRIA) for North America and serves as coordinator to all other regions/countries for GRIA completion maintaining all regional documentation in the field action file
• Assists in preparation of distribution reports as needed for field action preparation
• Supports MMS field action team in customer letter drafting, gathering stakeholder feedback, and finalization
• Maintains the “official record” field action file, ensuring all documentation is complete and appropriately filed in accordance with department standards to facilitate easy retrieval for audit support
• Tracks recall activities to closure and prepares the final closure documentation for each field action file
• Compiles field action data in support of MMS Management Reviews
• Ensures all SharePoint data is complete for metric reporting
• Provides documents in support of MMS audits as needed
• Manages data requests from other departments for field action activities
• Manages MMS related Canadian recall related activities within the NA PMQ organization, including customer letter creation, review and finalization
• Participates in post market surveillance data review meetings as needed in support of MMS field action activities
• Serves as a team member and/or leader on projects for the department as assigned
• Supports revisions to policies and procedures related to the MMS field action process as needed
• Participates in the development, review, issuance and training of BD policies and procedures related to Post Market Quality
• Develops solutions to routine assigned activities of moderate scope and complexity

Qualifications

• BA or BS degree, with minimum of 1-2 years relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry
• Preferred: Experience with post market surveillance and/or post market quality, expertise in participating in both internal and external audits, experience in 21CFR 806 and Canada Recall Regulations, experience with medical devices containing software, experience working within software management systems, such as, ERP and QMS systems