Quality Assurance and Regulatory Affairs Manager
Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager who will responsible for implementation of Regulatory strategies and Quality across their business.
·As a member of RA/QA & Compliance department, support in the creation and the changes of documents that describe companies in accordance to requirements of ISO 13485:2003, 21CFR820 QMS and other regulatory requirements.
·Support the effective implementation of Companies Quality Systems within the organisation.
·Contribute to the creation and implementation of training processes and training tools for companies employees in Ireland.
·Responsible for some quality assurance processes such as: change control, corrective actions and preventive actions, management of non-conforming issues, customer complaints, supplier evaluation, and internal audits.
·Responsible for document and record control process, custody and archiving of documents.
·Facilitate the communication with CMO's for documentation control and documentation/batch record review.
·Responsible for assigned products release.
·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
·The ideal candidate should have a degree in science or related discipline with at least 5 years of 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.
·Aworking 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.
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255