Executive Vice President (f/m/d) - QM & RA
Medical Devices EMEA (Home Office based)

The Company:

We are representing a globally active medical device manufacturer, that was founded and is still headquartered in Germany. The mission is to bring the development, production and sales of innovative implant systems within the interventional cardiology to the next level. With roughly 300 employees globally and roughly 100 of those working in Regulatory Affairs, Quality Management and Clinical Affairs, the team works continuously for two decades to develop and bring new products to the patients. Those products are designed to provide patients with a significant improvement in quality of life, who are beyond established treatments. This includes de-novo therapies and new technical approaches for established structural heart diseases. They follow a quality strategy and aim to increase the visibility of QM & RA in the Executive Board and want to reduce the time-to-market for new products to continue the successful delivery of first-in class products. We are therefore searching for the newly created position as Executive VP QM &RA who can be located within Europe - ideally in Scandinavia, Germany, Austria, Switzerland or Turkey.

The Position:

• Defines and executes the Quality Management and Regulatory Affairs vision in alignment with the overall coporate strategy
• Leads, coaches and develops the direct reports and the whole organization with focus on enabling the employees to grow and the processes becoming more efficient
• Represents internally and externally the topic of QM & RA and ensures visibility on the Executive Board level and is repsonsible for cross-departmental board projects
• Works closely with other areas of the organization or their environment (e.g. the CEO, Clinical Affairs, Sales & Marketing, R&D, Site Managers, notified bodies, research & consultancy agencies etc.)
• Analyses and carefuly adjusts the organization from an entrenpreneurial perspective, while enthusing the organisation from the overall vision
• Should always challenge the status quo of processes and drive the respective innovation in alignment with the overall corporate strategy
• Takes responsibility that the products (risk class IIb) meet performance and safety requirements
• Provides operative QM & RA leadership support for the direct reports and works closely with them to identify and evaluate upcoming trends

Your Profile:

• Experienced in Quality Management & Regulatory Affairs within the medical device industry, preferred in an international environment (here MDSAP) with a comparable risk class of IIb or higher
• Bachelor degree or equal in engineering, technical/ scientific discipline or related area/ equivalent background and experience
• Excellent communicator, excellent people manager - leadership character with proven success in such a role
• Creative thinker, out of box, interested in new technologies and trends focusing on the business outcomes
• Excellent understanding of the international, regulatory framework (CE ISO 13485, FDA 21 CFR 820 etc.)
• Flexible, ethic personality, who is able to communicate on a corresponding level, both internally and externally
• Ownership and entrepreneurial can-do mindset
• Interested to work with other cultures, sensitivity to cultural differences and able to facilitate them (team work with globally distributed teams and high profile partners)
• Fluent in English. German, Scandinavian, Turkish or any other European language is a plus, but not necessary
• Achievement orientation
• Conceptual thinking
• Convincing others
• Relationship building
• Process oriented

Your Chances:

• You are going to head an international, very professional and experienced team
• The onboarding and initial training is going to be individualized according to your prior experiences
• You are joining an organization with an established portfolio including monopoly products in a strong expansion phase and a full product pipeline
• The position provides you with ample decision making leeway, enables you to work flexible and influence your professional environment directly
• You are can not only make the difference, you are making the difference - in direct reporting line to the CEO
• The excellent company culture with a flat hierachy enables you to get things done
• You are going to find ideal foundations to grow and define your career in an expansive and dynamic company and to leave a mark in the industry as well as for the patients