Quality and Regulatory Affairs Manager
- Permanent
- Medical devices
If you have a broad interest in everything that concerns quality within an organization in which the patient takes central stage and if you like to stay abreast of legislation, this position may be the next step in your career within the life sciences industry.
Vacancy information
For an innovative and sustainable player of medical solutions in the health sector, we are looking for a QA & RA Manager for the Belgian market.
Range of tasks:
- Two major pillars are central: quality & regulatory responsibility
- You perform analyses of the various organizational processes in function of quality with the aim of offering and guaranteeing optimal control
- You translate the strategy into concrete projects in the context of quality standards with the aim of continuous improvement.
- Preparing, leading and following up on audits both internally and externally
- You define, update and approve procedures in accordance with regulations
- You identify bottlenecks and report to management
- You manage a project in which you also have an active role
- You are in constant dialogue with the various teams within the company (warehouse, customer service…)
- You provide advice, education and training on MDR (medical device regulation) and ISO certification
Requirements information
- At lease a bachelor degree, supplemented with at least 5 years of work experience within QA/RA, customer service or another support function
- Knowledge of MDR legislation is definitely an asset
- Experience in ERP systems
- Strong analytical thinker (risk assessment)
- Highly structured
- Solution oriented
- Business oriented
- Mature personality
- Stress resistant
- Fluent trilingual EN/FR/DU
