Senior Consultant Clinical / Regulatory Affairs
Netherlands, Germany, France, Belgium or United Kingdom (BW, BY, NRW)
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 and fast-growing consulting, training and CRO organization in the Medical Device and In Vitro Diagnostics sector with our largest base in the Netherlands, and local teams in Germany, 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/Regulatory Consultant you provide support to our clients in the medical device industry on a project basis with the (re)writing of clinical and regulatory strategies, clinical protocols, IB’s, literature searches, clinical evaluation plans and reports (CEP/CER), or improving technical documentation. You may participate in the management of clinical studies, and support our clients with approval processes and key strategic decisions in relation to regulatory and clinical affairs. You represent Qserve speaking at conferences showing our leadership in regulatory and clinical compliance, provide training both in-house and public and contribute internally to coaching others, and 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 technical/clinical field (chemistry, (medical) biology, biomedical technology, pharmacy or similar).
- At least 7 - 10 years working experience in the medical device sector (industry or in combination with a notified body) in functions with a strong clinical and regulatory responsibility.
- The ideal candidate has previously worked as Clinical Research Associate (CRA), Clinical Study Manager or Clinical Project Manager and in Addition, is experienced in writing Clinical evaluation reports (CER) and other clinical regulatory documents.
- Knowledge of Medical Device Regulations (EU MDR, FDA, PAL, TGA, etc.), GCP and ISO 14155 particularly in relation to generating and evaluating clinical data of medical devices.
- Pragmatic, 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 from small start-ups to large multi-nationals, accurate and analytical.
- Strong organizational skills, detailed oriented to deal with different projects at the same time.
- Fluent in English.
- Working permit and driver’s license.
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). 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.
The function is mainly home-based; we expect our consultants to work at the client location, from home or from our office in Arnhem, the Netherlands depending on the need.