QA and Regulatory Supervisor

Job Listing No: 9740000

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.


Apply for this job.

Similar Jobs For "QA and Regulatory Supervisor"

 Jobs by Indeed job search

Patient Care Technician - PCT

Location: Buckhannon, WV 26201
Report unusual findings to nurse supervisor. Report any complaints or observations to the nurse supervisor. Report any change or unusual findings to the nurse... To apply for this job vacancy in FRESENIUS you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 19 days ago

Equipment Operator 1

Company: Key Energy Services
Location: Jane Lew, WV
Accurately complete and turn in regulatory and compliance paperwork associated with job duties (DOT logs, load sheets, trip reports).... To apply for this job vacancy in Key Energy Services you must be qualified and you should prepare the required documents, click on the job link for more details.
Posted 30+ days ago

Note: This job listing with titled "QA and Regulatory Supervisor" was indexed from different job portals. This job might be expired or closed for accepting CV's so we suggest to browse it from the new jobs menu of this site. Our website is an open community website for assisting job seeker so if you found some broken links or error in our site don't hesitate to contact us to fix the issue. Thank you for using our free services.

Get updated on daily job vacancies!

Be updated by pressing the Facebook Like or G+1 button bellow.