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QUALITY ASSURANCE MANAGER / REGULATORY COMPLIANCE OFFICER(RCO)

·         Create quality policies and quality objectives and communicate them throughout the company,

·         Create processes to understand and meet applicable requirements from customers, as well as regulations at any applicable level.

·         Ensure that the quality objectives and quality policy are aligned with the QMS, and with the company’s strategic goals

·         Hold accountability for the effectiveness of the Quality Management System

·         Foster continual improvement

·         Monitor that product delivered to the market meets Quality and Safety standards.

·         Support other functions (Purchasing, Logistics, Engineering) for evaluation of Supplier´s and subcontracted third parties.

·         Maintains computerised record system with formulations and monitoring and verifying records.

·         Maintains factory processes and procedures to standard by using statistical methods for monitoring and charting. Notifying production supervisor of any noncompliance.

·         Releases materials by evaluating all results and visual inspection methods; determining status of non-compliant and/or usable material.

·         Maintain quality by following organisation standards (ISO 13485, MDR 207/745, ISO 14971, IEC 60601..)

Raise and Manage all necessary Non Compliant Records and Customer Complaints for review and analysis.
Suitable maintenance and analysis of records to establish trends and provide a basis for early identification of improvement needs.
·         Identify and report any quality or compliance concerns and take immediate corrective action

as required.

REGULATORY MANAGER

·         Maintain up-to-date knowledge and understanding of current regulatory requirements throughout the company and for all markets where the products are distributed

·         Monitor and communicate standard version updates and new or updated medical device regulations.

·         Interact with Distributors and provide them with needed documents to obtain Authorizations to market the products in their local markets.