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Regulatory Affairs Specialist - Expired

Job Title Regulatory Affairs Specialist
Job Type Permanent
Industry
Salary €0.00 per annum + Competitive Salary+benefits
Location Clare, Republic of Ireland
Start Date ASAP
Our Reference BBBH583_1500285433
Job Advertised 3 months ago

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:


  • 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

  • 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

  • Maintain regulatory oversight, plan and implement change programs to ensure continued compliance.

  • Identify and maintain key essential quality KPIs including regular reporting of regulatory metrics and issues

  • 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 five 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 hosting regulatory body, notified body and customer audits.

  • Interpersonal skills and professional skills to interact at all levels including senior management, contractors and colleagues.

  • Experience of ICH E6 GCP requirements would be an advantage

  • 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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