Sr. Specialist, Post Market Quality - Onsite

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
• Preferred: Expertise in participating in both internal and external audits
• Preferred: Experience in 21CFR 806 and Canada Recall Regulations
• Preferred: Experience with medical devices containing software
• Preferred: Experience working within software management systems, such as, ERP and QMS systems