Director of Quality & Regulatory
Location - Munich, Germany
Job type: Permanent
Director of Quality & Regulatory drive the vision, strategy, management and evolution of the Quality Management System (QMS) and pre/post market regulatory processes. You will ensures that all processes needed to operate the quality management system are established, implemented and maintained as well as the promotion of awareness of the requirements of authorities and customers throughout the organization. The position will have peer status with other members of the management team and will be responsible for the Quality Management and Regulatory Affairs with the overall objective of ensuring the high quality standard, reputation and conformity.
- Forming a sustainable quality culture based on compliance to regulations, patient safety, and continuous improvement of quality processes to benefit the end customer.
- Partnering with the business leadership team to drive wing-to-wing product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle.
- Managing the Quality Management Reviews.
- Acting as the interface between EMEA and the global QA/RA function, implementing central programs in an appropriate compliant manner.
- Driving training, enhancement, and adoption of the QMS framework and tools.
- Providing effective guidance and oversight for quality assurance and regulatory processes, as well as owning key decisions for the total product life cycle.
- Ensuring compliance to existing and applicable global Quality Systems Requirements.
- Translating new industry trends and requirements into business policies and practices
- Staffing and managing a globally disperse team of QA/RA professionals with the required skills and experience to execute their job responsibilities.
- Bachelor's degree in Engineering or other scientific disciplines.
- Minimum of 10 years Quality Management/Regulatory Affairs experience in the medical device or other regulated industry
- Minimum of 5 years working in a leadership roles or similar.
- Practical experience and good understanding of product development, manufacturing, quality control and servicing in a medical environment.
- Medical basic knowledge about relevant medical applications.
- Knowledge about products, processes and workflows in the field
- Good Knowledge about relevant national and EMEA wide directives and regulations i.e. EU-MDD, ISO 9001/13485
- Strong decision making skills and work towards tight deadlines
- Team player with experience in global matrixed organizational structure; global mindset
- Verbal and written fluently in German and English
If you are interested in the position, apply online today.