QA/RA Manager

Description

Quality & Regulatory Manager

Main Responsibilities:

Quality Systems

• Manage and continuously improve the Medical and General Quality Systems necessary, and support and define the Procedures and Processes to be followed throughout the Operation. Essential systems being ISO 13485, ISO 9001, ISO 13485 CMDCAS, 21CFR820.
• Maintain new and revised standards, and publications.
• Support Notified Body Audits
• Working together with all Departments to ensure that quality adherence and measurement is integral to the business.

Quality Management

• Define, manage, promote, and report progress of Quality Policies, Objectives and Plans. Perform Quality Management Review, in accordance with Quality system requirement. Key activities include, Internal Auditing, key Supplier Auditing, Product sign off, analysis and handling of Non-Conformances, Inspections, driving Corrective Action, and maintaining Equipment Certification.
• Monitoring of Customer Enquiries and Service Team activities to ensure necessary information is reviewed and fed back for awareness of Product Performance, Continual Improvement, and Vigilance, in case of Adverse Incident situations, or Complaint.

Quality Reporting

• Provide regular information and feedback to Directors on current and an impending issues and business metrics, and at set intervals provide formal reports.

Quality Training and Guidance

• Provide on hand support as required and formal training if necessary, to staff and departments to help ensure continued compliance to required procedures and processes.

Regulatory Systems

• Maintain compliance with new or ongoing Regulatory requirements of specific territories. Essential tasks ensuring, renewal of annual Establishment listings, and Device listings.

Regulatory Submissions

• Product reports are required for new products, and thereafter annual reports submitted (FDA) to maintain required accessions details, essential for product entry though customs.
• New submissions include technical file compilation in accordance with the requirements of the territory concerned, e.g. 510(k) for US, Medical Device Licencing for Health Canada. Other territories may involve preparation of technical file documentation.
• All ROW territories require support in both obtaining and legalising Certificates through Government Depts, and Consulates as necessary.
• Advice and liaison with local agents and distributors is required for such regulatory submissions in most cases, except for direct submissions such as USA and Canada.

• Any other duties as required by the Managing Director.

If you would like more information in regards to this role then please send your cv and or contact Bethany on