The position includes leading and executing the company’s Quality Assurance and Regulatory Affairs activities:

1. Planning, establishing, maintaining and representing the management in all quality activities through the company; reporting to the management on Quality system performance and its effectiveness; manage customer complaints and corrective actions; statistical data analysis and reports and function as the management representative.
2. Responsible for the preparation of regulatory agencies applications, reports, and communications worldwide
3. Manage activities such as audits, regulatory agency inspections, or product recalls.
4. Formulate and implement quality and regulatory affairs policies and procedures to ensure that quality and regulatory compliance is maintained.
5. Provide quality and regulatory guidance regarding design, development, evaluation, and marketing of products.
6. Overseeing and assuring quality processes of manufacturing activities – in-house and at assembly line
7. Implement and monitor customer complaint processing systems to ensure effective and timely resolution of all complaint investigations.
8. Review the company’s materials such as website, marketing literature and user manuals to ensure that quality and regulatory requirements are met.
9. Perform activities focused on the development, maintenance, and storage of product documentation to obtain domestic and international registrations.
10. Provide training in quality and regulatory policies and procedures for company’s employees.
11. Responsible for maintaining fluent professional relationships with relevant subcontractors.

Requirements:

• BSc (or higher) Degree or other relevant degree
• At least 3 years of experience in global QA/RA activities and in medical device company.
• English in mother tongue level. Ability to read and write technical documents in the highest quality and have fluent discussions and communications with regulatory authorities.
• Ability to work independently as well as part of a team.
• Excellent interpersonal and communication skills
• Knowledge of good document management practices