QA/RA Director

About the company:

The company has developed a naturally sourced, bioresorbable dentin graft material for the repair and augmentation of bone defects

Responsibilities:

1-The QA&RA Director is a member of the top management being involved in the concept decisions and realization of the company products including: Operations, Manufacturing, R&D, Finance, Quality Assurance, Regulation, Sales and Marketing.

2- The QA&RA Director is the Management Representative in accordance with ISO 13485 requirements having the responsibilities and authorities which are required in order to:

• Ensure that quality system requirements are effectively established, implemented and maintained in accordance with applicable regulatory requirements.

• Promote awareness of customer and regulatory requirements and assuring compliance to those requirements throughout the organization.

3-The QA&RA Director is the Person Responsible for Regulatory Compliance (PRRC) in Europe in accordance with the requirements of the EU MDR 2017/745 and in other countries as well, in accordance with local legislation and regulation. The QA&RA Director is responsible to ensure that:

• The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.

• The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.

• The post-market surveillance obligations are complied.

4-The QA&RA Director is responsible for managing all QMS and RA activities including: 

• Develops and implements quality management strategy and plans.

• Documentation control including writing, approval and maintenance of procedures, specifications, DHF, DMR/ MDF and technical files.

• Suppliers and subcontractor’s management, approval and on-going evaluation including conducting supplier and subcontractor’s audits as required.

• To conduct internal audits, initiate and monitor corrective and preventive actions and prepare and conduct Management Reviews.

• Monitoring of manufacturing, quality control, maintenance and calibration activities.

• Develop and execute PMS/ PMCF plans.

•  Change control activities including required verification and validations activities.

•  Promote and monitor Risk Management activities.

Job Requirements

Interpersonal and good communication skills                      

Technical skills            

Self-learning skills.   

Demonstrated organizational and time management skills                         

Ability to work effectively under pressure   

Knowledge of product and process related standards                     

Familiarity with medical device regulations in EU, FDA and other countries and ISO 13485 requirements.                              

Languages: Hebrew- native speaker, English- advanced level

One of the following requirements shall be fulfilled:

• A diploma from a well-known academic institute or a university in engineering, medicine, pharmacy or other relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. Or,

• At least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.