Post Market Surveillance Specialist

We are seeking a motivated and skilled individual to support the development and execution of the Post Market Surveillance (PMS) Reporting Program's activities to meet Elekta's regulatory requirements and collate customer intelligence to enhance our products and solutions.

Requirements

• Develop and maintain work instructions and schedules of the PMS Reporting Program.
• Collect, review and analyze post-market data including customer feedback, complaints, service reports, and field performance data.
• Collaborate with SMEs for input, analysis and reviews of PMS reports and data.
• Maintain and execute the Post-Market Surveillance Plans in accordance with applicable regulations.
• Conduct trend analysis and signal detection to identify potential product issues or emerging risks.
• Prepare PMS reports, Periodic Safety Update Reports (PSURs), and other regulatory documentation.
• Support complaint investigations by collaborating with Engineering, Product Management, RA and Medical Affairs.
• Ensure timely escalation of safety-related issues and support risk management updates.
• Participate in cross-functional reviews to drive corrective and preventive actions (CAPA).
• Monitor regulatory changes and ensure PMS processes remain compliant and up to date.
• Contribute to internal audits, external audits and regulatory inspections.
• Maintain accurate records and documentation in compliance with quality system requirements.