Senior Regulatory Supervisor

Senior Regulatory Supervisor
Excellent opportunity for an experienced Regulatory Supervisor to join in a fast growing, world renowned medical devices company. The overall purpose of this role is
  • To demonstrate a primary commitment to patient safety and product quality.
  • Understands and complies with all the regulations governing the quality systems.
  • Establish and maintain effective quality system structures to ensure consistent implementation of quality systems at the site.
  • 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.
Key Responsibilities include:
  • 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 company 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 company Quality System policies and procedures.
  • Collect and analyse 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.
Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the company Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
The ideal candidate will have
  • Level 8 Quality Qualification Essential
  • 3/5 years relevant work experience in a quality role
  • Along with good communication, organisational and problem solving skills
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