Quality Assurance & Regulatory Affairs

Surrey  ‐ Onsite
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Description

Responsibilities:
* Managing, developing and maintaining our ISO 27001 Quality Management System
* Leading the implementation of an ISO 13485 QMS from the ground up
* Rolling out an electronic document management system
* Conducting internal and external audits as required
* Identifying areas of non-compliance and implementing initiatives to apply corrective actions to ensure future compliance.
* Manage Notified Body relationships and interactions with other regulatory/government bodies (e.g. FDA, EMA, NICE, etc.)
* Preparing and collating technical documentation in the appropriate form for CE and FDA review
* Monitoring and responding to regulatory changes in legislation in all regions that the company operates or sells its products in
* Tracking quality metrics and keeping the executive leadership team informed through leading quarterly review meetings
* Creation and management of a business wide continuous improvement quality culture
Minimum Requirements:
* Bachelor's degree, preferably in an operations or business discipline
* 3 years of relevant working experience
* Prior experience operating within an ISO-controlled environment, ideally ISO 13485, 27001 and/or 15189
* Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
* Well-organized and detailed oriented professional, with strong verbal and written communication skills
The Ideal Candidate Will Have:
* Master's degree or higher
* 5+ years of relevant working experience
* Prior direct experience implementing an ISO quality system in an organisation from the ground up, ideally 13485
* Prior direct experience obtaining a CE mark for a medical device product
* Prior direct experience rolling out an electronic document management system
* Extensive understanding of the EC Medical Device Directive requirements
* Prior exposure to ISO 15189 and/or experience working in a "wet lab" environment
* A strong understanding and literacy of IT and information/data security (e.g. networks, servers, database management, cloud computing, etc.)
If you are interested in this role please contact Oliver Davies on or apply here
Start date
08/2015
From
Real Staffing
Published at
22.07.2015
Project ID:
950147
Contract type
Permanent
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