Jobs in Penicuik, midlothian, united kingdom

Job Description

Job Role

Are you looking to join a global Medical Equipment Manufacturing organization that aims to empower diagnostic insights, transform patient care, and innovate for life?

The PMS / Risk Specialist role is part of the Quality Systems team responsible for managing various quality systems, including the product Post Market Surveillance (PMS) and Product Risk Management Files throughout the entire product life cycle.

The focus of this position is to ensure compliance with all relevant regulations through the completion of Product Risk and PMS activities. The PMS / Risk Specialist 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, and Complaint Management) for products on the market.

Key Responsibilities

• Ensure Product Risk Management Processes comply 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 to required schedules to ensure regulatory compliance.
• Create and / or update PMS documentation in line with IVDR requirements and according to the agreed PMS schedule (PMS Plan, SSP, PMS Report, PSUR).
• Ensure Product Risk Management & PMS Process efficiency according to KPIs.
• Act as a Risk Management Team Representative during Third Party Audits.
• Promote risk culture, including a Risk-Based Approach and 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 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.
• Perform any other duties reasonably requested by the Company from time to time.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and appropriate regulatory requirements.

You must have full RTW in the UK to be considered for this role.

If you think you are right for this role, please apply with your CV or send an e-mail to [email protected] .

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