Senior Consultant with pharma experience
The Netherlands, Belgium, Germany, France, United Kingdom
Qserve offers professionals an international career in the medical device industry. We welcome people with drive and entrepreneurship, who feel challenged to advance their personal development and help grow our company in a diverse international setting. With the world of device and pharma regulations converging further, you will be entering a challenging work field.
Qserve Group is a fast-growing global organization with a multi-cultural team across the United States, Europe and China, operating at the forefront of technology in the medical device sector. We work in global teams for medical device manufacturers in all parts of the world. Our core values are honesty, quality, courage and pragmatism and we welcome positive people who enjoy growth and taking on new challenges.
We are looking for a consultant on medical devices with a pharma background, to support the growing business of combination products and companion diagnostics in elements of quality and regulator affairs.
Does this sound like the job for you? Then Qserve, a growing organization with a lot of operational freedom to its staff, a high level of exposure and a steep learning curve, is looking for you:
Senior consultant with pharma experience to support combination products.
This is what you will be doing at Qserve:
As Senior Consultant, you provide support to our combination product clients in the medical device industry on a project basis with the (re)writing of clinical and regulatory strategies, authority communications (notified bodies, drug agencies) and improving technical documentation in both devices as well as CTD format. You do this for mainly EU and US market approval processes. You may support our clients with approval processes and with key strategic decisions in relation to regulatory and often clinical affairs. You represent Qserve speaking at conferences showing our leadership in regulatory compliance of combination products, provide training both in-house and public and contribute internally to coaching others. 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 the knowledge base and brand of Qserve).
And this is what you will bring:
The ideal candidate has:
- A technical or scientific degree (MSc or PhD) in a technical/clinical field (pharmacy, pharmaceutical technology, chemistry, (medical) biology, biomedical technology or similar).
- At least 5 - 7 years working experience in the pharmaceutical and/or medical device sector (industry or in combination with a regulators job) in functions with strong regulatory responsibility.
- Knowledge of Medical Device Regulations (EU MDR, FDA, PAL, TGA, etc.), GMP and ISO 13485 particularly in relation to regulatory affairs.
- 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 multinationals, accurate and analytical.
- Strong organizational skills.
- Fluent in English.
- Working permit and driver’s license.
Is this your DNA?
Do you find pride and energy in working with highly educated professionals in an international environment? Are you a strong communicator with a solid sales profile and like being creative in finding solutions? Please look at our career opportunities at Qserve. We would like to get in contact with you!
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 IVD sector. We offer flexibility and diversity in terms of clients, devices, technology, roles and projects. We work together, to learn from and be part of a strong international team with technical, regulatory, quality and clinical competences (altogether over 500 years 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 in the dynamic and innovating world of medical devices? Then please submit your resume and letter of motivation to firstname.lastname@example.org or use our application form below.
For more information about our company, you can always visit our website (www.qservegroup.com) or contact our HR department at +31 20 78 82 630.
The position is home-based.