Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist

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 database of similar devices, survey collection and analysis, trend reporting, and proactive/reactive feedback.
• Strong analytical and problem-solving skills, with the ability to analyze data, identify trends, and develop actionable insights.
• Detail-oriented with strong organizational and documentation skills.
• Strong analytical skills with the ability to interpret and analyze complex data sets.
• Excellent attention to detail and ability to work independently and prioritize tasks effectively.
• Familiarity with adverse event reporting systems is preferred.
• Knowledge of statistical analysis methods and tools is a plus but not mandatory.
• Ability to adapt to changing regulations and industry trends.
• Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.

Our Awesome Benefits!

• PTO
• 401k with Employer Match
• Paid Time Off and Paid Holidays
• Employee Events
• Discounts for home, travel, entertainment and relaxation!

About Us

Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing…