Senior Regulatory Affairs Supervisor
Job ID: JOB-11454
Regulatory Affairs Supervisor
My client is a Munster-based Medical Device company with sites around the world! There is a new position available for a Regulatory Affairs Supervisor who will join a well-established team and lead the further growth and development of the department.
The key focus of your role as the RA Supervisor is to demonstrate a primary commitment to patient safety and product quality throughout your group. Also to create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards. Provide support to customer as required helping to ensure delivery of highest quality product.
- Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams. Is viewed as a leader in the areas of quality systems and ISO/MDD standards within one’s own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis.
- Implementation of internal requirements and external laws, regulations, guidance’s and standards as applicable to the quality systems.
- Champions continuous improvement and innovation from a quality system perspective.
- Lead and support site External Inspections.
- Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize the Quality System policies and procedures.
- Collect and analyze business/quality system process data from different parts of the company.
- Support the site corrective and preventive actions process.
- May on occasion be required to travel in order provide support the business or other sites in this area of responsibility.
- Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
- Degree qualified (Level 8) in Quality qualification
- +4 years of experience in Regulatory Affairs in the Medical Device industry.
- People Management/Supervisory experience
For further information on this role please contact Clara Burke on 086 816 8273 or firstname.lastname@example.org
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