Regulatory & Quality Affairs Manager

·      Lead the QA/RA inspections in preparing, coordinating, tracking, and following up on approvals for medical device submissions including US 510(k), EU technical files, Israel, New Zealand, Thailand and more, as applicable.

·      Research, plan, prepare, and obtain approvals for medical device submissions in growing global markets.

·      Responsible for leading and coordinating both Quality and Regulatory inspections and audits, including preparation for company external audits by 3rd parties (CE and FDA) to ensure full compliance.

·      Prepare, review and approve product development documents, including test product requirements, risk analysis documents, clinical validation protocols etc.

·      Provides internal training on understanding, interpretation and implementation of global standards and regulations.

·      Works closely as key team members along with R&D, Quality, Clinical, Product management and Business on all aspects of product life cycle.

·      Represent Regulatory Affairs on change controls and provide comprehensive regulatory assessments to support product and process modifications.

·      Review and approve marketing communication materials.

·      Act as liaison for communication with regulatory authorities or distributors regarding the company’s regulatory filings.

·      Remain current developments in field(s) of expertise, regulatory requirements, and industry trends.

·      Develop Annual Quality Planning , administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.

·      Review, approve and execute all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments etc.

·      Continuous improvement of Quality Assurance processes and procedures.  

·      Responsible for Annual Internal Audits, planning and implementation 

·      Establishing Quality Objectives based on KPIs (Key Performance Indicators ) 

·      Root cause analysis and implementation of corrective action for process related concerns. 

·      Analyze failures, corrective and preventive actions to respond to internal/external customer complaints. 

·      Support the quality inspections to ensure projects, products and processes comply with the relevant requirements of the QMS  

·      Planning Company Training and implementation as required by the Quality management system 

·      Planning of new employees Onboarding

·      Responsible for communicating with notified bodies regarding quality related issues 

·      Conducting management reviews, collection and data analysis 

·      Management of the Risk Management process 

·      Implementing and maintaining the Quality Management System (QMS), that complies with ISO 13485:2016, FDA 21 CFR Part 820, ISO 27001, GDPR, HIPAA.