Risk Manager (m/w/d) Medical Devices

Join D.Med Consulting GmbH – Pioneering Medical Device Technologies

D.Med Consulting GmbH, headquartered in Hamburg, Germany, is a joint venture between Fresenius Medical Care AG (51%) and the D.Med Healthcare Group (49%). Founded in 2011, we are a leading provider of research, development and consulting services specializing in extracorporeal therapies. The collaboration with Fresenius Medical Care, the world leader in renal care, and the D.Med Healthcare Group, a renowned provider in nephrology, cardiology, and internal medicine, allows us to offer a comprehensive range of services from concept to implementation. Join our team of dedicated professionals and contribute to groundbreaking advancements in medical device technology. Join us and experience a true partnership in innovation – working hand-in-hand to achieve our customer goals.

For our office in Hamburg and at the earliest possible starting date we are looking for a

Risk Manager (m/w/d) Medical Devices

Your responsibilities

• Identification, analysis, evaluation, and documentation of product and process-relevant risks for medical devices acc. to ISO 14971 and other applicable regulations
• Evaluating the safety relevance of hazards or hazardous situations in collaboration with technical experts
• Supporting the project teams in the technical development and implementation of risk control measures and analyzing their effectiveness
• Supporting the identification, investigation, and GAP Analysis of regulatory requirements for medical devices
• Supporting the creation, review, and update of technical documentation
• Supporting the creation of market access & registration strategies for active and non-active medical devices as well as SaMD
• Supporting the creation, review and update of Quality Management System Documentation incl. all relevant documentation
• Supporting the regular screening of worldwide regulatory requirements

Your profile

• Solid academic foundation in fields such as medical technology, engineering, computer science, or physics, or equivalent expertise through a comparable qualification.
• Ideally 2-5 years of professional experience in risk management, quality management and regulatory affairs of medical devices
• Good technical understanding of systems with mechanics, software, and hardware.
• Good Knowledge of MDR, ISO 14971, ISO 13485, IEC 62304 and safety analysis (FMEA, FTA)
• Excellent communication and team player skills
• Independent and results-oriented way of working
• Good analytical and decision-making skills
• Fluency in German and English (written and spoken) – another language is a plus

What we offer

• A diversified and challenging environment combined with a high degree of freedom for the implementation of innovative ideas
• A permanent employment contract with performance-related pay at an international and promising employer
• A modern workplace in spacious and bright offices in the heart of Hamburg with a view of the River Elbe
• A supportive working atmosphere in a dynamic team with short decision paths
• An individually tailored “on the job” training and professional development opportunities
• Personal added values such as a company pension scheme, team events, employee discounts, bike leasing and much more

Do you see this job offer as a personal challenge and do you want to make a difference? Then share your application, including your salary expectations and your earliest possible starting date, with us by clicking on “Apply for job” or via application@dmed-healthcare.com.

We are looking forward to meeting you!

D.Med Consulting GmbH | Bernhard-Nocht-Str. 99 | 20359 Hamburg | +49 211 650 415 14