Description
Roles and Responsibilities- Develop, implement, and maintain company's Quality Management System and maintain ISO 13485:2012 certification;
- Responsible for the pre-market and post-market applications to secure compliance to market products in the EU, USA, Canada, and other markets with relevant Regulatory Authorities;
- Develop, implement, and maintain company Quality Manual, Procedures, and Policies;
- Develop and maintain CE Technical Files for a range of devices from Class I to Class IIb;
- Manage CAPA system including Vigilance incident reports, including the investigation of complaints and incidents;
- Oversee Internal Auditing and Management Review Schedule;
- Liaise with Original Equipment Manufacturers and other suppliers concerning Quality and Regulatory issues;
- Assist in the preparation of Design and Development documentation for Notified Body approval which includes Clinical Evaluations;
- Manage Quality Assurance Department including projects assigned to QA/RA;
- Develop and write clear arguments and explanations for new product licenses, variations and license renewals;
- Report to the Managing Director concerning actions to be taken to comply with Quality and Regulatory requirements;
- Create understanding within the company of primarily European but also other relevant regulatory requirements.
Skills and Competencies
- Knowledge of 93/42/EEC as amended by /EC
- Knowledge of ISO 13485:2012
- Experience in the construction and maintenance of CE Technical Documentation
- Experience in pre-market and post-market approval
- Experience of dealing with Vigilance and/or customer complaints procedures