Post Market Surveillance Specialist

Who we want

The Post Market Surveillance Specialist is responsible for in country coordination and execution of activities related to complaint reporting, Filed Actions and Commercial holds implementation, acting as a Business Partner and ensuring post market surveillance is managed in line with regulatory requirements and company procedures.

What you will do

• Execute post market surveillance activities for Poland (complaints and incidents, Field Actions, Commercial Holds) in line with defined procedures and processes.

• Manage communication related to post market surveillance activities with Operations, Technical Service and Sales as well as the Polish Competent Authority,

• Develop close collaboration with the central post market surveillance teams and local partners

• Provide guidance and advise on PMS requirements to affected stakeholders

• Support internal and external audits and management reviews.

• Identify opportunities for continuous improvement and support those activities across RAQA.

• Support local RAQA team as needed to complete activities outside post market surveillance area

• Perform based on established targets and objectives for RAQA.

What you need

• Fluency in Polish and English (C1 or higher level)

• Educated to university degree level (Business / Legal / Life Sciences preferred)

• Self-starter with a pro-active approach

• Experience in a medical device regulatory or quality role would be an added value

• Understanding of EU MDR post market surveillance requirements and obligations preferable

• Strong organizational problem-solving and analytical skills

• High attention to detail and process consciousness

• Ability to handle multiple projects and meet deadlines, working closely with RAQA Specialists and Managers across the region.

• Strong IT skills, including Microsoft Office

• Experience in TrackWise system would be an advantage