Our medical device client is a very well regarded award winning company with facilities around the world. We have been retained to assist them in recruiting a QA / RA Supervisor for two of their Irish facilities. One in Munster and one in Connaught.
This role is an ideal role for an individual seeking to make that next step into a senior level/supervisory role within the medical devices sector. Both roles will be based on site 5 days a week and will see the role holders manage site teams in quality and regulatory.
Our client is eager to meet with individuals with excellent quality experience and an understanding of the regulatory function or vice versa.
Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System.
This will cover:
- Management of the PMR system.
- Change Control Process.
- Documentation Control system for the QMS.
- Ensuring continuous compliance with the following:
- FDA Quality System Regulation 21 CFR 820 (QSR)
- Medical Device Directive
- Health Canada Medical Device Regulations
- ISO13485 Medical Device Quality Management System
- Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
- Any other applicable market regulation
- Provide advice on regulatory affairs requirements for all proposed changes to device design.
- Compilation of regulatory submissions:
- CE Mark registration,
- 510(k) registration,
- Technical Dossiers and
- similar applications and notifications
- annual reports, supplements and registrations.
If you would like to find out more about this role or have an initial confidential discussion about it, then contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706 or email: email@example.com