Job Type: Head of Quality Management and Regulatory Affairs
Key Responsibilities of the Head of Quality Management and Regulatory Affairs:
- You are responsible to provide regulatory input to new product developments and product lifecycle planning for the entire product line of the company.
- Lead assessments of certification processes according to MDR and EN ISO 13485
- Lead internal audits for affiliates worldwide
- You develop multi-country regulatory strategies to support the business
- Lead in Support and training of clients and colleagues
Key Requirements of the Head of Quality Management and Regulatory Affairs:
- Bachelor/Master degree in sciences, life sciences, engineering, software development
- 3 + years' experience in Medical device industry
- Strong Experience within Technical Documentation.
- Extensive knowledge of standards such as ISO 13485
Benefits for the Head of Quality Management and Regulatory Affairs:
- Competitive benefits and great personal development opportunities.
- Great atmosphere within a vibrant team.
- Leading Learning & Development Support both internally and externally
- Flexible working hours
- Home Office
- Great interactions between different teams - Chance to explore other departments
- Flat Hierarchy Structure