Regulatory Affairs Post Market Specialist

What you'll do

• Manage and design processes for post-market surveillance activities.
• Support clinical evaluations by integrating real-world data into regulatory submissions.
• Identify trends and early-warning signals through systematic literature reviews.
• Drive continual improvement to ensure compliance with global regulations.
• Facilitate corrective or preventative actions based on product performance issues.
• Prepare monthly reports on key quality measures for post-market surveillance.
• Coordinate across departments to support a robust post-market system.

What we're looking for

• 6+ years of experience in quality systems, post-market signaling, real-world evidence tracking, and regulatory reporting.
• Demonstrated ability to lead issue resolution and apply structured problem-solving methods.
• Expertise in continual improvement, risk management, and advanced root cause analysis.
• Experience authoring medical device submissions (e.g., 510(k), EU Technical Documentation).
• Knowledge of quality management systems and relevant regulations (ISO 13485, IEC 62304, 21 CFR parts 803, 820).
• Ability to adapt to changing priorities in a fast-paced and evolving business environment.
• Experience with software as a medical device (SaMD) or equivalent in the medical device industry.