Post Market Surveillance Specialist

Crawley - UK

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Are you a current Elekta employee

Please click here to apply through our internal career site Find Jobs - Elekta.

Want to join a team with a mission to improve and save lives

We continually look for motivated and skilled individuals who are interested in supporting our customers healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

TITLE Post Market Surveillance Specialist

REPORTS TO Head of Clinical Solutions LSS Product & Technology

DESCRIPTION

This position supports the development and execution of the Post Market Surveillance (PMS) Reporting Programs activities to meet Elektas regulatory requirements and collate customer intelligence to enhance our products and solutions. This role is responsible for monitoring analyzing and reporting on product performance once released to the market identifying trends that may impact product safety or quality. The post-holder manages the timely production and submission of reports in accordance with schedules. You will also support

internal and external audits of the PMS program.

RESPONSIBILITIES

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.

AUTHORITIES

Communicate PMS Reporting to authorities on behalf of the business

Represent the PMS Reporting Program in internal and external audits

Represent the PMS Reporting Program in meetings and escalations

Required Experience:

Are you a current Elekta employee Please click here to apply through our internal career site Find Jobs - Elekta.Want to join a team with a mission to improve and save lives We continually look for motivated and skilled individuals who are interested in supporting our customers healthcare professio...