PMS (Post-Market Surveillance)/Risk Specialist
Company: AliveDx
At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we prioritize patient health by creating innovative solutions designed for faster diagnostic results.
Location: Near Edinburgh (EH26 0BF)
Role Overview: The PMS/Risk Specialist will ensure compliance with all relevant regulations through the completion of Product Risk and Post Market Surveillance (PMS) activities. This role involves managing risk throughout the Design Control Process for new projects and through Core QMS processes for products on the market.
YOUR MISSION
Your main responsibilities will include:
* Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations.
* Conduct all duties in compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
* Provide support, guidance, and training to team members in Risk Management and PMS.
* Maintain knowledge of new or updated regulatory requirements and industry standards.
* Participate in regulatory inspections or certification audits.
* Promote risk culture within the organization, including Risk Based Approach and Continuous Improvement.
* Act as a Risk Management Team Representative during Third Party Audits.
* Create and update PMS documentation in line with IVDR requirements.
* Carry out PMS activities for compliance with required schedules.
* Lead and support all Product Risk Management activities.
YOUR COMPETENCIES
* Science Degree or Equivalent qualification.
* Experience in risk management.
* Experience in Post Market Surveillance activities (PMS).
* Ability to prepare coherent regulatory reports.
* Specialist knowledge of regulations applicable to medical devices and in vitro diagnostic medical devices.
* Great attention to detail, communication, and collaboration skills.
WHAT WE OFFER
* A dynamic and growing environment.
* An opportunity to cultivate innovation and customer centricity.
* A flexible working environment and a range of benefits including pension, private medical cover, life assurance, and more.
Interested? We look forward to receiving your application.
AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Manufacturing and Science
Industries
Biotechnology Research and Medical Equipment Manufacturing
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