QA&RA Lead

CONMED is a global medical technology company that specializes in the development and manufacturing of surgical devices and equipment. With a mission to empower healthcare professionals to deliver exceptional patient care, CONMED is dedicated to innovation, quality, and excellence in all aspects of our operations. You will be responsible for the quality system of the French sales organization. Furthermore, you are part of our EMEA Quality Assurance and Regulatory affairs team where you will be responsible for regulatory releases for the EU as well as executing activities that needs to be done authorized representative. In this role you will be reporting directly to the Sr Directory Quality Assurance and Regulatory Affairs International. Key Duties and Responsibilities: · To maintain the quality management system in your region · Training and coaching people on the procedures and processes · Monitoring quality objectives and metrics · Ensure that local regulations with respect to regulatory compliance, privacy and ESG are followed · Ensure that CAPA’s and NCR’s are closed in due time · Ensure that recalls and shipholds are executed without delay · Prepare and lead the quality management review meetings · Facilitate internal and external audits · Ensuring that local registrations are done in a timely manner · Being the contact person for regulatory requests from larger distributors · Ensure that suppliers and distributors are approved · Regulatory verifications as per Article 13 & 14 of EU-MDR · EU-REP and CH-REP regulatory duties (Technical reviews and Vigilance reporting) · Support EMEA Export Required Experience and Skills: · Relevant Bachelor’s degree · 3 years’ experience in a quality assurance or regulatory affairs role · Language skills: good written and verbal English and French communications skills required. Prefered Skills: · Relevant Master’s degree · 5 years’ experience in a quality assurance or regulatory affairs role · Good knowledge of local and European Medical Device regulations · Certification as auditor for ISO9001 or 13485 is preferred · IT literacy, experience with using Microsoft Office applications, · Strong communication skills · Passion for quality and to do things right

Location: France, FR

Posted Date: 2/5/2025