Vitalograph is the world's leading manufacturer of medical Spirometers, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in cardio-pulmonary clinical drug trials. Based in Ennis, Co. Clare for over forty years, we now wish recruit the following personnel;

Regulatory Affairs Specialist
This role requires a person with a strong technical qualification and wide-ranging experience of medical device global regulatory issues, particularly the US FDA and EU MDD requirements.
Responsibilities:

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Ensure compliance with the following medical device & software quality requirements
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EU Medical Device Directive
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ISO13485 Medical Device QMS
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FDA QSR 21 CFR 820
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Japanese JPAL requirements
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Health Canada SOR 98/282
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Chinese CFDA requirements
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FDA 21 CFR 11 guidance
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ICH E6 GCP
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Host regulatory body and customer onsite and remote audits
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Prepare Regulatory filings
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CE device approvals
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FDA 510(k) submissions
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Japanese JPAL submissions
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Health Canada submissions
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Competent Authority registrations
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Maintain the product and establishment registrations
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Maintain regulatory oversight, plan and implement change programs to ensure continued compliance.
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Identify and maintain key essential quality KPIs including regular reporting of regulatory metrics and issues
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Prepare and submit annual plans with focussed targets and associated budget.
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Manage product quality through co-ordination of goods receiving QC, in process QC and final inspection release activities.
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Travel to other sites to work as part of duties will be required.

Qualifications and Experience

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Minimum BSc/BEng degree in a science or technical discipline with a relevant postgraduate qualification a distinct advantage.
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Have completed post-qualification quality and regulatory courses
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Minimum five years' experience in medical device quality and/or regulatory areas
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In-depth understanding of both FDA Class II and EU MDD Class IIa medical device requirements and regulations.
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Experience of hosting regulatory body, notified body and customer audits.
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Interpersonal skills and professional skills to interact at all levels including senior management, contractors and colleagues.
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Experience of ICH E6 GCP requirements would be an advantage
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Strong problem-solving and analytical skills

If you are interested in the above position please email a CV to careers@vitalograph.ie or by post to; Regulatory Affairs Manager, Vitalograph, Gort Road Business Park, Ennis, Co. Clare.
For more information on Vitalograph Ireland Ltd. Please visit www.vitalograph.ie

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