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Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
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Details

QA/RA Associate


Reference:AKFY-047535 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed


Our client a North American Healthcare company who have recently established an Irish operation are currently seeking a Quality Assurance and Regulatory Affairs Associate to join their team. Reporting to Director or Regulatory Affairs and Compliance and successful candidate will contribute to the implementation of Regulatory Strategies and Quality Assurance Processes for Products Commercialized by company. Successful candidate will ideally have experience in Regulatory Affairs and Quality however candidates with a background in quality who would like to gain experience in Regulatory could be considered

Role/Responsibilities:

Create and implement the training processes and training tools for employees.
Lead the creation and the changes of documents that describe procedures for activities controlled by company for all its products and in accordance to requirements of ISO 13485:2003, 21CFR820 QMS and other regulatory requirements where company will establish development and commercial activities.
Responsible for some quality assurance processes such as: customer complaints, change control, corrective actions and preventive actions, management of non-conforming issues, supplier evaluation, and internal audits.
Responsible for document and record control process, custody and archiving of documents.
Assist in the creation of regulatory submissions for clinical studies approval and commercial approval for medical devices with regulators in Canada, USA, Europe and Rest of the World.
Facilitate regulatory support and guidance to internal and external stakeholders on regulatory requirements.

GENERAL REQUIREMENTS / QUALIFICATIONS:

The ideal candidate should have a degree in science or related discipline with at least 5 years experience in quality assurance and regulatory affairs of medical devices. Quality Assurance and/or Regulatory experience in similar regulatory environments such as pharmaceuticals or biotechnology will also be considered, although preference is given to medical device experience.
The ideal candidate has played a role in the implementation of quality management systems, as well as experience in filling regulatory submissions.
A working knowledge of ISO 13485, QSR, GMP, GCP, GDP processes and regulatory requirements and guidelines is desired.
Strong analytical, technical, and organizational skills, ability to handle multiple projects and multiple deadlines, as well as excellent interpersonal and communication skills are imperative for this role.
Experience in dermatology and wound healing would be an asset.




James Cassidy | Tel: +353 (0) 1 5079250