Clinical Trials, Medical Device, Quality/Risk Management, Regulatory Compliance
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs or auditing in medical devices. We are a worldwide operating organization that is fast-growing offering consulting, training and CRO in the medical device and in-vitro diagnostics sector. Our headquarters are located in The Netherlands, and local teams in Germany, UK, USA and China.
Is this your DNA?
Do you find pride in supporting customers in line with professional and ethical values? Do you have a practical approach and like being creative in finding solutions? Do you enjoy the diversity of working with different devices and companies at the edge of innovation? Please take a look at our career opportunities at Qserve. We would like to get in contact with you!
This is what you will be doing at Qserve:
As a Senior Clinical Consultant, you provide support to our clients in the medical device industry on a project basis with the (re)writing or independent development of clinical strategies, clinical evaluation plans and reports (CEP/CER), or performing literature searches. You support our clients with approval processes and key strategic decisions in relation to regulatory and clinical affairs. You may represent Qserve speaking at conferences showing our leadership in clinical compliance, provide training both in-house and at public venues and contribute internally to coaching others and 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 with a minimum of 7-10 years of relevant experience or an Advanced degree (MSc or PhD) with a minimum of 5-8 years of experience in the medical device sector in functions with a strong clinical and regulatory responsibility.
Ability to develop clinical strategies independently with clients
Knowledge of global Medical Device Regulations (EU MDR, FDA, PAL, TGA, etc.), particularly in relation to generating and evaluating clinical data of medical devices.
Pragmatic, accurate, analytical, enjoying a mix of activities with various device technologies, business processes, regulatory and clinical challenges.
Communicative and service-oriented, supporting a wide variety of clients.
Strong organizational skills, detail-oriented to deal with different projects at the same time.
Fluent in English.
Legally able to work in the US, e.g. an appropriate work visa or permanent resident alien status (green card).
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 and in-vitro diagnostics 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, clinical, regulatory and quality competences (altogether over 800 years of experience).
Besides a balanced set of core benefits and a competitive salary based on experience, Qserve offers benefits such as sick time, health insurance and the flexibility of working home-based.
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.
The function is mainly home-based. In addition, we expect our consultants to visit the client location from time to time, and travel internationally on an annual basis for our global annual meeting in The Netherlands.
Internal Number: Qserve_1234
About Qserve Group
Qserve is the largest EU Consultancy for regulatory, clinical and quality compliance. Our global footprint includes offices in the Netherlands, UK, Germany, China and on both coasts of the USA.
Our primary focus is on medical devices & in-vitro diagnostics making Qserve your one partner for worldwide regulatory compliance. Our benchmark is the unique combination of a global reach, high level expertise and a team with diverse field experience.
We are highly specialized in Regulatory Affairs, Quality Assurance, Clinical Affairs, CRO, Training, Auditing, and Global Registrations. With our hands-on practical approach, we strive to be your premier partner in accelerating market approval, providing customized advice, and guiding clients with their compliance & requirement needs with a considerable focus on:
• MDR EU Market Access
• IVDR US Market Access
• China Market Access
• CRO Services Clinical Trial Access
Our consultants have worked for medical device manufacturers, European Notified Bodies and, US FDA or Chinese CFDA. Our goal is to guide our clients with our practical approach, translating existing & developing regulations into understandable requirements.