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.

Schedule: Monday - Friday: 8:30 am - 5:00 pm

Location: 5855 Oberlin Dr, San Diego, CA 92121 / Remote option available

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!

• Health Plans,Dental Plans, Vision Plan
• 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 center that provides high quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative product improvement initiatives through its Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen's products are FDA regulated and ISO certified.