Technical Consultant Electro-Medical Active Devices
Europe, United States
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs or auditing in the area of medical devices. We are a worldwide operating and fast-growing consulting organization in the medical device sector with our largest base in Europe, the Netherlands, and local teams in China and USA.
Is this your DNA?
Are you passionate to help customers? Are you able to find the right balance between business needs and quality of work in the interest of the customer, while always staying close to ethical and professional values and pride in the work that you deliver? Do you have a practical approach and creative in finding pragmatic solutions with projects? We would like to get in contact with you!
This is what you will be doing at Qserve:
As a Senior Technical Consultant for Active Devices at our company you provide specialist consulting services, auditing and training in electro-medical device (active device) regulations, software, clinical evaluation, and strategic support to medical device manufacturers. With the objective to obtain or maintain or expand market access for our customers to various markets (EU, USA, China). As a consultant, you build technical documentation in support of CE marking, 510(k), or similar approval processes. Your activities may include strategy planning, reviewing and developing technical documentation, clinical evaluations and quality management systems (ISO 13485). You may conduct internal or supplier audits, help improve our customers quality processes, and provide technical support in IEC 60601 series, usability (e.g. to IEC 62366 and/or IEC 60601-1-6) and software products (EN 62304) compliance.
You maintain, develop and share your expertise and knowledge on a specific expert area. On this specific expert area, you will be the point of contact for colleagues and customers. You will pro-actively follow the news and trends in the market to share within our Knowledge Center (blogs, whitepapers, news items, presentations or similar to promote knowledge base and brand of Qserve).
And this is what you will bring:
- You have a technical or scientific degree (MSc or PhD) in physics, electrical engineering, biomedical technology or similar.
- Minimal 7-10 years working experience in the field of electro-medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA), in either manufacturing, R&D, quality or regulatory roles.
- (Experience working at Notified Body, test houses preferred)
- (Experience as an auditor to ISO 13485:2016, MDSAP, MDD, MDR a plus, but not required).
- Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) (and quality management would be a plus, but is not required)
- Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs, quality assurance or clinical affairs.
- Communicative and service oriented, supporting a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
- Strong organizational skills, detailed oriented to deal with various projects at the same time.
- Fluent in English.
- Working permit the United States, The Netherlands, Germany, United Kingdom or Belgium.
Why choose Qserve?
Qserve has an international and dynamic work environment in which you can learn, develop and operate in the innovative, fast-moving medical device sector. We offer flexibility and diversity in terms of clients, devices, technology, roles (author, reviewer, expert, trainer, auditor, etc.) and projects. Work together, learn from and be part of a strong international team with technical, regulatory, quality and clinical competences (altogether over 500 years of experience). And last but not least we offer a balanced set of core benefits that we believe are important to all employees.
“Global reach, practical approach, experienced team”
Getting excited about a career as a consultant in the dynamic and innovating world of medical devices and in-vitro diagnostics? Then please submit your resume and letter of motivation to email@example.com or use the form below.