Post Market Surveillance and Risk Specialist- Medical Technology

Risk Management and Post Market Surveillance Specialist

We are working with a global biotechnology and healthcare organisation to find an experienced Risk Management and Post Market Surveillance specialist.

The company offers a comprehensive benefits package along with opportunities for professional growth and development.

The Role:

• Ensure that Product Risk Management Processes comply with relevant regulations.
• Lead and/or support all Product Risk Management activities according to current procedures and guidelines.
• Create new and update existing Product Risk Management documentation to ensure compliance with current procedures.
• Carry out Post Market Surveillance (PMS) activities for products in adherence with the required schedules to ensure regulatory compliance.
• Create and/or update PMS documentation in line with regulatory requirements and in accordance with the agreed PMS schedule (PMS Plan, SSP, PMS Report, PSUR).
• Evaluate and improve the efficiency of Product Risk Management & PMS Processes according to established Key Performance Indicators (KPIs).
• Act as a Risk Management Team Representative during Third-Party Audits.
• Contribute to Continuous Improvement initiatives.
• Participate in regulatory inspections or certification audits as part of the Quality Systems Team.
• Maintain knowledge of new or updated regulatory requirements, guidance documents, and industry standards related to your areas of responsibility.
• Provide support, guidance, and training as needed to fellow team members in the areas of Risk Management and PMS.

Requirements:

• Degree in a relevant scientific discipline.
• Experience in the medical device/IVD/Biotech industry is essential.
• Experience in risk management and post market surveillance activities.
• Ability to analyze data and author reports.