Regulatory Affairs & Quality Assurance Expert Consultant
To contribute to the smooth operation of the Regulatory Affairs & Quality Assurance Department as well as support the department’s and team’s performance, KPIs and daily activity.
- Provide professional, high level and smooth client service;
- Perform various Notification work associated with the RA/QA department;
- (Product Classification, Pre-Market Notification, National Registration, Free Sales Certificate Application, GMDN Code Verification, Communications with EU Authorities, etc) at the highest level;
- Follow-up on tasks assigned to him as well as coordinate tasks assigned to a small team (more than 5);
- Ensure regulatory and scientific research on requirements;
- Support the development and design of a new method, system and resource;
- Support preparations for Management & Board Meetings;
- Assistance to Managers, Department Managers and/or Unit Directors;
- Provide internal trainings on department related matters;
- Contribute to online and offline publications;
- Contribute to the implementation of ISO 9001:2008 and ISO 13485:2003;
- Participate to Obelis events.
- MA Degree in Economy, European law, Pharmacy, Chemistry or Quality Management Systems (or similar).
- 3 -5 years’ experience in project management and Quality Management systems (QA/RA);
- Experience managing a team;
- Professional experience in EU Administration is considered an asset;
- Scientific background is considered an asset;
- Familiarity with Cosmetics and or Medical Devices is considered an asset.
- Fluency in English (written & oral);
- Any other languages are always a plus.
- Proficiency at Microsoft Word, Excel, PowerPoint, Outlook.
Desired skills & Competencies:
- Strong knowledge of Quality Management systems;
- Exceptional ability to manage the execution of multiple projects without error, and with high attention to detail;
- Customer and Solution oriented;
- Strong analytical abilities;
- Ability to prioritize, coordinate and manage tasks;
- Excellent time-management skills;
- Ability to assume responsibilities;
- High adaptability, flexibility, dedication supported by a positive ‘can-do’ attitude;
- Strong oral and writing skills to be able to communicate effectively internally and externally;
- Ability to structure workflow within a team;
- Ability to take own initiatives;
- Ability to motivate team members;
- Be able to and willing to travel in/out of the European Union.