We are seeking an experienced professional to join our Medical Device organization based in Cork. This is a great opportunity for individuals who want to work with a leading multinational company that excels in its field.
Duties and Responsibilities
* Ensure validation activities comply with US and EU regulations, GBSC procedures, and EHS requirements.
* Review and approve documents prepared by project teams, other departments, and contractor organizations (e.g. protocols, reports, change controls).
* Assist in the development of validation strategies and plans for equipment and process validations.
* Support the QA Validation team leader in driving improvements within the Validation and Change Control processes.
* Participate in cross-functional teams as required.
Requirements
* In-depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485, and European regulations associated with the medical device industry.
The ideal candidate will have excellent communication and problem-solving skills, with the ability to work independently and as part of a team.
Salary: €45,000 - €60,000 per year.