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Job Title: Corporate Regulatory Leader
Location: Ireland
Discipline: Regulatory
Reference: CMMQ6831
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Description: Audit/ Regulatory / Risk Management/Medical Laboratories/
CMMQ6831
Corporate Regulatory Leader
Ireland
This is a Head Position in Ireland for a Global Pharma/Drug/Med
Device Company. This position has respossibilities for the following:
-Lead the Regulatory Affairs and Auditing groups.
-Maintain a customer complaint handling program that meets
applicable requirements.
-Provide support for Regulatory Affairs related issues.
-Manage the Internal Audit program.
-Co-ordinate the preparation and execution of external audits.
-Provide leadership to the site in the identification, investigation and
resolution of customer-quality related issues.
-Train and develop employees within the department
-Maintain a customer complaint handling system in compliance
with division requirements and applicable external requirements
-Provide the necessary support for effective handling and timely closing
out of customer complaints and associated follow-up activities
e.g. Risk Evaluations
-Report metrics to site and division management regarding complaints,
investigations and external communications.
-Bring to the attention of Quality Management areas of risk for
product/batches on market.
-Provide support to investigators in the Scientific Support areas.
-Provide update and maintain status of product registrations and
notifications.
-Provide documentation to Area Regulatory Affairs for product
registrations and notifications outside the European Union.
-Coordinate vigilance and post market surveillance activities.
-Establish and maintain the Internal Audit schedule. Report progress
against audit schedule.
-Conduct company's business in a manner that will protect human
health, safety and the environment by complying with all applicable
EH& S laws, as well as the the company's global & technical SOP's
Qualifications: Minimum Requirements
. Advanced Degree Relevant/ Masters Prefered
.7 years experience in Quality, Documentation, Regulatory
or Manufacturing areas within the pharmaceutical or devices
industry of which 5 years were with people management.
· Working knowledge of Quality Standards and Regulations
e.g. ISO 13485, IVDD etc.
· The ability to work co-operatively and effectively with others to
establish and maintain good working relationships.
· The highest level of integrity in the successful completion of your work.
· Advanced leadership skills in order to build an effective team by
providing clear direction and define priorities.
· Proven problem-solving skills.
.Able to relate and recognize local irish customs with respect
in conducting day to day business
Apply to: Click Here
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