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- Aufgaben: Identify and evaluate risks for medical devices while collaborating with project teams.
- Arbeitgeber: D.Med Consulting GmbH is a leader in medical device technology, backed by Fresenius Medical Care.
- Mitarbeitervorteile: Enjoy a permanent contract, modern office, training opportunities, and perks like bike leasing.
- Warum dieser Job: Be part of groundbreaking advancements in healthcare and work in a dynamic, supportive team.
- GewĂĽnschte Qualifikationen: Solid background in medical tech or engineering; 2-5 years in risk management preferred.
- Andere Informationen: Fluency in German and English is required; additional languages are a plus.
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
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”.
We are looking forward to meeting you!
D.Med Consulting GmbH | Bernhard-Nocht-Str. 99 | 20359 Hamburg | +49 211 650 415 14
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Risk Manager Medical Devices (m/f/d) D.Med Consulting GmbH Arbeitgeber: D.Med Healthcare
Kontaktperson:
D.Med Healthcare HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Risk Manager Medical Devices (m/f/d) D.Med Consulting GmbH
✨Tip Number 1
Familiarize yourself with ISO 14971 and other relevant regulations. Understanding these standards will not only help you in the interview but also demonstrate your commitment to the field of risk management in medical devices.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in risk management. Engaging with experts can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past work that showcase your analytical and decision-making skills. Highlighting your experience with FMEA or FTA will be particularly relevant for this position.
✨Tip Number 4
Showcase your fluency in both German and English during the interview. Being able to communicate effectively in both languages is crucial for collaborating with diverse teams and stakeholders.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Risk Manager Medical Devices (m/f/d) D.Med Consulting GmbH
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Risk Manager position. Understand the key responsibilities and required qualifications, especially regarding risk management and regulatory affairs in medical devices.
Tailor Your CV: Customize your CV to highlight relevant experience in risk management, quality management, and regulatory affairs. Emphasize any specific knowledge of ISO 14971, MDR, and safety analysis methods like FMEA or FTA.
Craft a Compelling Cover Letter: Write a cover letter that connects your background and skills to the specific requirements of the role. Mention your fluency in German and English, and express your enthusiasm for contributing to innovative medical device technologies.
Include Salary Expectations: As requested in the job description, be sure to include your salary expectations in your application. This shows that you have carefully considered the position and are serious about your application.
Wie du dich auf ein Vorstellungsgespräch bei D.Med Healthcare vorbereitest
✨Understand ISO Standards
Make sure you have a solid grasp of ISO 14971, ISO 13485, and IEC 62304. Be prepared to discuss how these standards apply to risk management in medical devices, as this will demonstrate your technical understanding and relevance to the role.
✨Showcase Your Analytical Skills
Prepare examples from your past experience where you successfully identified and mitigated risks. Highlight your analytical and decision-making skills, especially in relation to safety analysis methods like FMEA and FTA.
✨Communicate Effectively
Since excellent communication is key for this role, practice articulating complex technical concepts clearly and concisely. Be ready to explain how you would collaborate with project teams and technical experts.
✨Demonstrate Team Spirit
D.Med Consulting GmbH values teamwork, so be prepared to discuss how you work within a team. Share experiences that showcase your ability to support colleagues and contribute to a collaborative environment.
