- Reference: GJ43370
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
Reporting directly into the Chief Executive Officer, the QA & RA Director is responsible for maintaining and ensuring that the Company’s Quality Management System complies with FDA, ISO 13485 and international medical device regulatory standards.
- The QA & RA Director will act as the management representative for the company.
- The duty of this task is to act as the point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.
- Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.
- Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files.
- Responsible for the quality and regulatory control for products in which the company is the Legal Manufacturer.
- Manage and maintain compliance to ISO13485 requirements.
- Responsible for responding and reporting incidents to all approved markets.
- Responsible for the Customer Complaint System.
- Responsible for managing product failures and appropriate corrective actions.
- Responsible for defining the Company’s quality goals each year. Managerial responsibilities
- Manage the Quality Assurance and Regulatory department.
- Develop yearly target budget and capital plan.
- Manage QA & RA expenditure against budget.
Skills, Experience and Qualifications:
- A bachelor of Science Degree with 10+ years’ experience in Quality Assurance and Regulatory affairs within the medical devices field of use.
- At least 2 years management experience
For a confidential discussion and more information on the role/company please contact christopher.otoole on 091-706713 or email firstname.lastname@example.org
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