Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist

Join to apply for the Senior Post Market Surveillance Specialist role at Argen Corporation
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This range is provided by Argen Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

The Senior Post Market Surveillance Specialist will play a crucial role in ensuring the safety and compliance of our products in the post‑market phase. Supports Regulatory Affairs teams through the creation/maintenance of analytical tools and databases to facilitate Post‑Market Surveillance, Regulatory Compliance, Regulatory Submissions, Regulatory Intelligence review and product innovation/improvement activities. Responsible for conducting investigations, analyzing data, and identifying potential risks or regulatory/quality issues related to Argen products.

Demonstration of expertise in quality assurance and/or regulatory requirements will contribute to the continuous improvement of our products and processes.

The day‑to‑day:

• Develop, implement, and maintain post‑market surveillance processes and procedures to ensure compliance with regulatory requirements (e.g., FDA regulations, EU MDR) and industry standards.
• Coordinate and oversee product recall activities, including investigation, risk assessment, communication with relevant stakeholders, and coordination of corrective actions.
• Manage global field action activities, including identification, evaluation, and coordination of corrective and preventive actions to address product performance issues and safety concerns.
• Ensures timely and accurate Medical Device Reporting (MDR) and adverse event reporting to regulatory authorities as required.
• Conducts post‑market surveillance activities in compliance with applicable standards and regulations.
• Collaborates with cross‑functional teams, including but not limited to R&D, Business Development, Quality Assurance, Quality Engineering and Manufacturing, Operations, Supply Chain, Marketing, Sales, Customer Services, and Engineering to gather relevant information for investigations and ensure timely resolution of issues.
• Collect, evaluate, and analyze investigation data to identify trends, potential risks, and opportunities for product improvement.
• Prepares comprehensive reports on post‑market surveillance activities, field actions, reportable events, findings, and recommendations for management review.
• Maintains accurate and up‑to‑date documentation of investigations, including complaint files, investigation reports, and regulatory submissions.
• Stays current with relevant global regulatory requirements, industry standards, and best practices related to post‑market surveillance, vigilance, field actions, and reportable event.
• Participates in internal and external audits and assists in implementing corrective and preventive actions related to post‑market activities, as necessary.
• Participates in risk management activities, including the evaluation of product risks, identification of hazard mitigation strategies, and implementation of appropriate actions, as necessary.
• Provides training and guidance to other team members and stakeholders on post‑market surveillance processes, regulatory requirements, and best practices.

What does it take to be successful?

• Bachelor’s degree in Engineering, Science, Law, or other technical field with 4+ years of experience in post‑market surveillance, field actions, reportable events, or regulatory intelligence review, or an equivalent combination of education and experience. Advanced degree preferred.
• Solid understanding of quality assurance and/or regulatory principles, post‑market surveillance activities, and regulatory requirements (e.g., ISO 13485, FDA Regulations).
• Proven experience in global post‑market surveillance, field actions, reportable events, regulatory and/or intelligence review roles.
• Experience in coordinating and managing product recall activities, including risk assessments, communication plans, and corrective actions.
• Proficiency in conducting investigations and root cause analysis of field actions, adverse events, customer complaints, CAPAs, SCARs, public/regulatory…