Job Title: Risk Coordinator, Post Market Surveillance
Job Type: Full-time, permanent position
Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site. (Relocation support can be offered for the right candidate, however you MUST have the full right to work in the UK)
Remuneration: £35,000 to £40,000 + benefits
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Quality and Regulatory Department. This role is part of the Quality Systems team who is responsible for the management of the various quality systems, including the product Post Market Surveillance (PMS) and Product Risk Management Files throughout the entire life cycle of the Products.
The focus of this position is to ensure, through completion of the relevant Product Risk and Product Post Market Surveillance (PMS) activities, that products are maintained in compliance with all relevant Regulations. As part of this job, you will manage risk throughout the entire Design Control Process for new projects and through Core QMS processes (such as Non-Conforming Product management, Change Management, Complaint Management) for Products on the market.
Main responsibilities:
* 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 IVDR 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
* Promote risk culture including Risk Based Approach and Continuous Improvement
* Participate in regulatory inspections or certification audits as part of the Quality Systems Team
* Providing support, guidance and training as needed to fellow team members in the areas of Risk Management and PMS
* Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements
Requirements:
* Science Degree or Equivalent qualification.
* Previous experience working in IVD's/Medical devices.
* Risk Management or Quality Systems/Engineering qualifications/training.
* Ideally trained in ISO14971.
* Risk Management or Quality Systems/Engineering qualifications/training.
* Regulatory/Quality and/or customer audit experience.
For more information please reach out to lucy.kirkaldy@cpl.com
Please note this position does not offer sponsorship, however could offer relocation support for the right candidate.