Regulatory Compliance Officer (Post Market Surveillance)

SRG are working with a global biotechnology and healthcare organisation to help them find a Risk Management and Post Market Surveillance specialist to join the team.

The company offer a comprehensive benefits package along with opportunity for development.

The Role:

• Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations.
• Lead and/or support all Product Risk Management activities according to current procedures
• 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)
• Ensure Product Risk Management & PMS Process efficiency according KPIs.
• Act as a Risk Management Team Representative during Third Party Audit
• Contribute to Continuous Improvement
• Participate in regulatory inspections or certification audits as part of the Quality Systems Team
• Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards relating to your related areas of responsibility
• Providing support, guidance and training as needed to fellow team members in the areas of Risk Management and PMS

Requirements:

• Degree in relevant scientific discipline
• Experience in medical device/IVD/Biotech industry is preferred
• Experience in risk management
• Experience carrying out Post Market Surveillance activities (PMS)
• Ability to analyse data and author reports

Benefits:

• Private Medical cover
• Life assurance
• Additional annual leave
• Cycle to work scheme + more.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.