This role requires a manager with a strong technical qualification and wide-ranging experience of medical device global quality and regulatory issues, particularly the US FDA and EU MDD requirements.
* Ensure compliance with the following medical device & software quality requirements;
* EU Medical Device Directive
* ISO13485 Medical Device QMS
* FDA QSR 21 CFR 820
* Japanese JPAL requirements
* Health Canada SOR 98/282
* Chinese CFDA requirements
* FDA 21 CFR 11 guidance
* ICH E6 GCP
* Manage a QA/QC department of eight personnel
* Manage Supplier/Vendor quality through a comprehensive vendor management program.
* Perform reviews and audits as required.
* Host regulatory body and customer onsite and remote audits
* Prepare Regulatory filings;
* CE device approvals
* FDA 510(k) submissions
* Japanese JPAL submissions
* Health Canada submissions
* Competent Authority registrations
* Maintain the product and establishment registrations
* Supervise the document control function including approval of all change control requests (engineering change notices, deviations and rework instructions)
* Ensure upkeep of archives
* Control and manage the eQMS system
* Maintain regulatory oversight, plan and implement change programs to ensure continued compliance.
* Identify and maintain key essential quality KPIs including regular reporting of quality metrics and issues
* As Management Representative, co-ordinate management reviews and quality reporting to senior management
* Manage the Complaints program. Perform reportability reviews and interact with all stakeholders.
* Manage Issues and CAPA. Co-ordinate RCA and action plans with task owners.
* Be the site quality representative on design teams including risk management approvals, NPI and design transfer.
* Co-ordinate an Internal Audit program covering QMS and process audits.
* Participate in and give training on quality and regulatory matters including the eQMS.
* Prepare and submit annual plans with focussed targets and associated budget.
* Manage product quality through co-ordination of goods receiving QC, in process QC and final inspection release activities.
* Travel to other sites to work as part of duties will be required
Qualifications and Experience
* Minimum BSc/BEng degree in a science or technical discipline with a relevant postgraduate qualification a distinct advantage.
* Have completed post-qualification quality and regulatory courses
* Minimum ten years' experience in medical device quality and/or regulatory areas
* In-depth understanding of both FDA Class II and EU MDD Class IIa medical device requirements and regulations.
* Experience of implementing and maintaining ISO13485
* Experience of hosting regulatory body, notified body and customer audits.
* Interpersonal skills and professional skills to interact at all levels including senior management, contractors and colleagues.
* People management and supervisory experience.
* Experience of ICH E6 GCP requirements would be an advantage
* Experience of using and/or specifying an eQMS system would be useful
* Strong problem-solving and analytical skills
If you are interested in the above position please email a CV to email@example.com or by post to; HR Department, Vitalograph, Gort Road Business Park, Ennis, Co. Clare.
For more information on Vitalograph Ireland Ltd. Please visit www.vitalograph.ie