Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): 30,000 - 40,000
Benefits: Benefits Package
Our client, an innovating IVD manufacturer of molecular diagnostics systems, they are currently seeking an RA/QA Specialist who comes from an in-vitro diagnostics background. They could also consider splitting the position into two roles, 1 QA, 1 RA.
Regulatory Affairs & Quality Assurance Specialist - IVD's
Our client is an innovating IVD manufacturer of molecular diagnostics systems, they are currently seeking an RA/QA Specialist who comes from an in-vitro diagnostics background. They could also consider splitting the position into two roles, one QA, one RA so applicants who are more experienced in one area than the other should still apply.
This role would suit someone living within a commutable distance of Manchester, candidates who are open to relocation will also be considered.
Up to £40,000 dependant on experience plus benefits
Regulatory Affairs & Quality Assurance Specialist
* Collaborating with the Diagnostics Division to ensure all processes comply with relevant IVD and ISO 13485 regulations;
* Provide review, advice and guidance on interpretations, regulatory requirements and SOPs and participate as requested by management during inspections and audits by third parties
* Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects
* Assist in the creation and maintenance of DHFs and product technical files and ongoing activities related to compliance with European, and other regulations
* Assist in submission activities associated with regulatory approval of in-vitro diagnostic medical devices
* Assist with documentation for compliance and for changes requiring regulatory agency approval as pertains to EU and international regulatory requirements
* Provide support to currently marketed products, e.g. reviewing engineering changes, labelling, promotional material and product changes
* Assist with regulatory issues such as recalls or field safety corrective actions and advisory notices
* Supporting the QA/RA Manager with post-market regulatory compliance / surveillance activities for EU and International product approvals.
* Assist with customer complaints
* Consulting company personnel in achieving and maintaining regulatory conformity as a prerequisite to worldwide market access of IVD products
* Working together with R&D Management, as well as the Quality Manager to ensure efficient system effectiveness across the Personalised Medicine divisions
* The upkeep and further improvement of the Quality Systems and processes to ensure optimum compliance with relevant corporate and regulatory policies.
* Assist in the creation of standard operating procedures and policy guidelines
* Identify quality improvement needs and opportunities;
* Perform internal audits as required
* Support the QA/RA Manager in maintaining a QMS that meets the applicable regulatory and company requirements including ISO 13485 certification.
* Perform other duties as required or assigned by the QA/RA Manager
* Conversant with ISO 13485 and ISO 14971
* Auditing skills; Internal Auditor to ISO 13485 is desirable
* Knowledge of International Regulatory standards
* Knowledge of GHTF STED, and IVD CTS documentation requirements
* Attention to detail and organisational skills are paramount, as well as strong written and verbal communication skills
* Strong regulatory background within the IVD industry is essential
* Experience in Class 2a and Class 2b devices
* Strong team player providing support, guidance and expertise in achieving regulatory compliance and customer satisfaction by educating, analysing and facilitating improvements through interaction with peers and both internal and external customers
* High degree of initiative with ability to work in a fast-paced/entrepreneurial team environment
* Excellent time management skills, results- and goal-oriented
* Strong Proof Reading Skills.
* Highly Computer Literate (MS Word, PowerPoint, Excel)
* Root cause analysis techniques, FMEA and risk analysis techniques.
* Strong willingness to learn about changes in the regulatory (and Quality Management) requirements for in-vitro diagnostic assays and instruments
* Knowledge of Design control, Risk Management, Product Development processes
* Experience of Design History File and Technical File Preparation is desirable
This is an excellent opportunity for an experienced QA/RA professional to further their experience and work within a thriving oncological device business with products that are leading innovation in the field across the globe.
Please apply today or contact Joe Walker in the dedicated Medical Device Team for more information 01189 594 990
Clinical Professionals is Europe's leading provider of Life Sciences staff with a unique and dedicated medical device team with a deep rooted knowledge of Medical Technology and staffing. Our Medical Devices Team is focused on finding Clinical Research, Regulatory and Quality positions at all levels.
Medical Devices, In-vitro Diagnostics, IVD, IVDD, Regulatory Affairs, Quality Assurance, ISO13485, submissions, audit, QMS, molecular diagnostics, assay, assay development
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