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Head of Post Market Surveillance will play a critical role in driving Post Market surveillance and Complaint Handling for Philips Sleep & Respiratory Care products.
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In addition, the Clinical Affairs Program Manager will perform annual activities associated with Post Market Surveillance (PMS) program, including but not limited to, preparing and writing plans, reports and Post Market Clinical Follow-up (PMCF.
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This high-impact role will make direct contributions to highly visible projects such as new product introductions, obtaining market access for a specific product, continuous post-market surveillance, and pilots of emerging engineering technologies that are candidates for integration into current workflows.
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Prepare post-market surveillance reports, adverse event reports, and other regulatory reports. Prepare post-market surveillance reports, adverse event reports, and other regulatory reports.
$60,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provides quality compliance oversight of Pharmacovigilance (PV) to ensure Adverse Event, complaint management and post market surveillance are executed compliantly and in a timely manner.
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Maintenance of documentation and post market surveillance reporting are ongoing to maintain market authorization and require ongoing support for the assigned product teams.
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Lead the team of digital product focused cybersecurity engineers ensuring cybersecurity planning, assessments and requirements are determined, establishing security testing approaches as well as establishing a post market surveillance practice to cope with future addressed cybersecurity risks or identified vulnerabilities.
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Develop and implement post-market surveillance strategies, including complaint handling, adverse event reporting, and corrective and preventive action (CAPA) processes, to ensure ongoing product safety and regulatory compliance.
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Learning & Development Opportunities: On-demand online training and book reimbursement. In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO). Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485.
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5 years of medical device experience in the field of technical or medical writing, post market surveillance, clinical trials, or product risk management. Proven knowledge and experience in quality, regulatory, post market surveillance, post market quality, adverse event reporting, clinical trial design, or clinical trial.
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Knowledge of FDA regulations, including 21 CFR, 510(k), and PMA requirements. Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
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Partner with Regulatory Affairs for regulatory compliance decision-making impacting the global post market surveillance requirements for all CLSD products. The scope of accountability for this position includes providing quality oversight to all research & development, design, manufacture, and distribution of CLSD products, as well as the support, maintenance, and enhancements of the products post launch.
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This position is also responsible for Quality Engineering support related to post-market activities including complaint investigations, Health Hazard Evaluations, Risk Management, and Post Market Surveillance.
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Participate in Post-Market Surveillance (PMS) activities as required. Participate in FDA inspections, ISO Registration and surveillance audits and customer audits. Participate in Post-Market Surveillance (PMS) activities as required.
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Assess post market surveillance to assimilate customer feedback into meaningful product improvements. Identify market requirements and customer needs, translating these into marketing specifications for product development.
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