Consultant Medical Devices – Quality/Regulatory
The Netherlands, Belgium, France, Germany or the United Kingdom
As a consultant at Qserve, you will have a different focus every day varying from:
- Writing technical documentation
- Developing the optimal regulatory strategy to minimize the regulatory burden for a product
- Doing a supplier audit on-site
- Coaching manufacturers on their clinical strategy for a new innovative device
- Giving a day training in risk management.
You work with a variety of technologies, for manufacturers around the globe, either at home, in the Netherlands at our headquarter office or at the client. Sometimes along, or in a team with Qserve colleagues from other countries, we put the best available expertise together. Your learning curve is steep as you work at the forefront of medical technology innovation and with some of the world’s leading device manufacturers. And if you are challenged for solutions in a project, there is always a colleague in the wider Qserve global team who has the answer.
Does this sound like the next step in your career development? Then Qserve, a growing organization with a lot of freedom and a high level of exposure is looking for you:
A Regulatory professional in medical devices with a passion to help customers bring their products to global markets.
This is what you will bring:
- You have a technical or scientific degree (BSc, MSc or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology or similar.
- Various levels (minimum 5 years) of working experience in the field of medical devices (EU-MDD and EU-MDR) through positions in industry, consultancy or Notified Body, in either manufacturing, R&D, quality, regulatory or clinical roles (e.g. Manager Regulatory Affairs & Quality Assurance).
- Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) and/or quality assurance.
- 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 multinationals, able to adapt to different company cultures and situations.
- Strong organizational skills, detail-oriented to deal with various projects at the same time.
- Competent in communication, analysis and advice and taking ownership in your work and personal development.
- Fluent in English.
Qserve is constantly looking for professionals at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, clinical trials or auditing in the area of medical devices and in vitro diagnostic devices. We are a worldwide operating and fast-growing regulatory consulting firm and CRO in the medical device and in-vitro diagnostics sector with our largest base in Europe, and local teams in China and the USA.
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”
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 like being creative in finding pragmatic solutions? Then please take a look at our career opportunities at Qserve. We would like to get in contact with you
Getting excited about a career as a consultant 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.