NovaPump is an innovative cardiology company with international leading products in the field of catheter-based short-term mechanical circulation support devices (heart pumps) situated in the university town Jena, the scientific and industrial centre of Thuringia. Our company develops and manufactures class III medical devices and will market it together with strong international partners.
Head of Quality Management & Regulatory Affairs Department
You will lead our RA & QM management team in Jena and have close contact to the management, as well
our development and product management team.
Your work will focus on:
Leading our quality management & regulatory affairs department
Coordination of internal quality management processes and documentation
Communication & coordination of tasks with our notified body and other authorities
Lead the quality politics of our firm and improve our total quality management system within our firm culture
Coordination of external test procedures for our Class III cardiology products
Communication with our suppliers and external partners (e.g. R&D partners, university clinics as clinical
trial partners and state authorities)
Reports on status, changes or any news to the management and global team
We are looking for a candidate (m/f/d),
who has a technical scientific degree (minimum bachelor of science or engineer of mechanical engineering/medical engineering)
Deep Knowledge in medical device regulations and quality management (MDR, ISO13485)
Minimum of 3 years work experience in regulatory affairs departments or quality management in the medical industry and leading experiences
Exceptional knowledge of English and fluent in German
Very good social and communication skills
Have excellent in leadership, communication, organization, process planning and time management
Bring in industry experience form your former work in a quality management department preferable in medical device industry (esp. class III products)
Are a team player who likes challenges in an exciting, but family-like working team
Confident with standard office software and have a driving licence (class B)
then we can offer you not only an interesting job in our team with an open and inspiring work environment
which works hard to realize outstanding innovative and highest quality cardiology products, but also a couple of advantages for your new job
(company car, additional 13th monthly salary and a couple of other firm specific advantages).
Are you interested?
We look forward to receiving your application electronically as pdf file (over letter, CV, references) with your salary expectations and the earliest possible starting time to email@example.com
For additional information please visit our website at www.novapump.de
(as a supplem.: Lothar-Späth Award Winner in Gold in 2021 for its outstanding innovations)
Head of Quality Management & Regulatory Affairs Department (m/f/d) Medical Technology
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