R&D Regulatory Affairs Specialist - Expired
|Job Title||R&D Regulatory Affairs Specialist|
|Salary||Up to €0.00 per annum|
|Location||Clare, Republic of Ireland|
|Job Advertised||about 1 year ago|
R&D Regulatory Affairs Specialist
Vitalograph is one of the world-leading manufacturers of medical Spirometers, used in the diagnosis of respiratory disorders, and advanced high-reliability systems used in clinical drug trials. Based in Ennis, Co. Clare for over forty years, we now wish to recruit a R&D Regulatory Affairs Specialist to join our existing R&D team.
Reporting to the CTO, this role requires someone with at least 2-3 years' experience in a regulated environment. They will be familiar with activities required to ensure that Vitalograph's product and software development projects and deliverable are compliant with industry standards and regulations.
- Ensure that product development QMS SOPs are current and compliant.
- Conduct internal audits on product development projects to ensure compliance with regulatory requirements.
- Assist with the completion and ongoing maintenance of device technical files.
- Identify and mitigate project risks.
- Liaison with cross-functional R&D teams and intercompany project management teams.
- Regular communication of project status to relevant stakeholders.
- Qualifications: 3rd Level Degree in an Engineering or Science discipline
- 2-3 years in industry role with relevant experience
- Exposure to requirements of EN ISO 13485, MDD, MDR, FDA 510(k)
- Good knowledge of product development life-cycle processes
- Excellent communication skills both written and verbal
- Experience with Microsoft Excel, Word, Outlook
The following skills would be advantageous:
- Familiarity with Agile/Lean work practises
- Experience with product testing and certification
- Experience dealing with 3rd party test houses
- Experience acting as Subject Matter Expert in company audits