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Molecular diagnostics company specialized in developing and manufacturing automated systems and tests for detecting a variety of diseases.
Job Title: Post Market Surveillance Specialist The Post Market Surveillance Specialist is responsible for developing activities for Post Market quality.
The position will support the development, governance and integration of Post-Market Surveillance (PMS) and Vigilance processes and ensure effective execution into our Quality Management.
Main Responsibilities: Support activities during product recall or adverse event reporting activities (drafting reports, communication letters, disseminating communications, etc.)
Collect and analyze adequate data for Post-Market Surveillance purposes Support Post-Market Surveillance program of Cepheid devices by providing relevant PMS data and analysis for periodic post-market review meetings.
Prepare PMS deliverables in the frame of IVDR (PMS plans, PMS reports and PSURs) and other local regulatory requirements.
Work with cross functional IVDR teams to complete deliverables Support integration of the Post Market Process into all facets of the new IVDR regulations including Complaint Handling, Adverse Events Reporting and Field actions Partner with Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision.
Ensure compliance to 21CFR820, ISO 13485, and other quality systems regulations and regulatory standards, as applicable.
Prepare for, participate in and assist with Regulatory Authorities facility inspections, Notified Body Audits and other governmental inspections as directed.
Minimum Requirements: Bachelor level required 2 years of previous experience in the role and industry Strong understanding of quality systems methodology and applications.
Strong knowledge of Excel and other IT tools to build relevant dashboards Demonstrates knowledge of domestic and international quality systems and other standards such as IVDR/MDR, ISO 13485, ISO 14971 and other applicable standards and regulations.
Contract: 6 months contract Salary: according to experience Work Type: Full remote work Join us: Be part of a leading company in the IVD and Medical Device industry.
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