Description
We are looking for a Medical Writer to join our growing global medical device Quality and Regulatory team to support with product development and regulatory activities. 2San is a global distributor of medical device products falling broadly into three categories: Clean, Protect, Test. We are maintaining an ISO 9001:2015 Quality Management System, with some key Medical Device additional responsibilities such as: Quality Control, Supplier Management, Post Market Surveillance. The role of the Medical Writer will be to support the development of print/copy for products, utilising the clinical information available and adapting existing content to ensure a user-friendly output. Claims made must be considered in the context of the regulatory landscape for each region and the ideal candidate would have knowledge of this space.
Key Accountabilities / Responsibilities
* Support the Quality & Regulatory Strategy by suitable priotitisation of activities, timely response to time-critical activities, and thorough documentation of essential evidence and key decisions within the quality management system.
* Working with stakeholders, contribute to the development of a broad range of materials (product information, scientific publications, training materials, website content and meeting materials amongst others).
* Ensure good documentation practices and data integrity principles throughout the organisation.
* Ensure supporting evidence for QMS is well documented and retained within approved systems.
* Maintain KPIs and dashboards to show quality status against objectives, and performance of the system.
* Demonstrate the quality objectives in all activities and liaison with the wider business functions.
Measures of Success
* Quality KPI’s on weekly dashboard remain ‘out of the red’
* Activities completed within timelines stipulated in SOPs.
* KPIs are regularly updated and effectively monitored to minimise overdue in collaboration with other business areas.
* Lead by example and influence others.
Key Behaviours
* Resilience
* Organisation
* Integrity
* Flexibility
Skills & Experience
* Familiarity with ISO 9001 and other medical device legislation for quality management systems.
* Experience of varied maturities of QMS / eQMS platforms.
* Practical experience of working with stakeholders across the business.
* Documentation experience, process writing.
* KPI monitoring.
What Next
* Contact to request any further information relating to the role.
* Then please view position and apply via /careers/44
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APPLY FOR THIS JOB:
Company: ROR Nation
Name: Courtney Lee
Email: