QA and Regulatory Supervisor
QA and Regulatory Supervisor – Co. Wexford – €50-70K+ Benefits
My client are a medical device company who operate globally and employ around 1000 people in Ireland. They currently have an exciting opportunity for a Senior Quality Systems and Regulatory Supervisor to join their team. You will manage 7 people in total, 3 in the regulatory team and 4 in the document control team. Ideally you will have regulatory and quality systems experience but candidates with strong quality systems experience who are willing to up skill will also be considered. As Senior Regulatory Specialist you will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation.
Accountabilities as QA / Regulatory Specialist include:
Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System.
- Management of the PMR system
- Change Control Process
- Documentation Control system for the QMS
Leading the preparation and direct all activities for:
- FDA inspections
- ISO 13485 surveillance audits
- Corporate audits
- Internal audits
- Customer audits
- Customer complaint investigation, reporting, closure and trending
- Support other Lake Region sites with any queries relating to New Ross site that may arise during their audits
- Review current technical product files for compliance to international requirements
- Answer all customer regulatory requests and complaints
- Design and implementing quality systems improvements
- Support plant validation documentation programs as required, ensuring records are maintained
Qualifications and Experience
- College graduate with science / engineering related degree or equivalent experience
- Minimum 3-5 years experience in a Medical device quality systems role in an FDA regulated environment
- Previous supervisory experience essential
- Qualified systems lead auditor for ISO 13485 and MDD compliance.
- Competent in preparing written communication and correspondence.
- Previous Regulatory experience an advantage
This role is offering a generous package including health insurance for you and your family, profit sharing, pension, flexitime, free parking and canteen facilities. If you are qualified and interested please send your CV or call Clare on 0044 2890 339968 for more information. Base salary is negotiable.
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