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 essential
* Experience in risk management
* Experience carrying out Post Market Surveillance activities (PMS)
* Ability to analyse data and author reports