Regulatory Affairs Specialist - Expired
|Job Title||Regulatory Affairs Specialist|
|Salary||€0.00 per annum + Competitive Salary+benefits|
|Location||Clare, Republic of Ireland|
|Job Advertised||about 3 years 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.
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 firstname.lastname@example.org 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