Senior Regulatory Affairs Consultant Medical Devices
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 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 being creative in finding pragmatic solutions within your projects for customers? Then please 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 Sr. Regulatory Affairs Consultant in our company you provide specialist consulting services, auditing and/or training in medical device regulations, quality assurance, compliance, 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) and based on predetermined and agreed deliverables.
As a consultant, you may build (technical) documentation and design dossiers in support of CE marking, 510(k), or similar approval processes. Your activities may include strategy planning, reviewing and/or developing technical files, clinical evaluation reports and quality management systems. You may conduct internal or supplier audits, or deliver interim QA/RA management, or help improve our customers quality processes.
You maintain, develop, and share your expertise and knowledge in a specific expert area. In 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 the knowledge base and brand of Qserve).
And 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.
- Minimal 7 to 10 years 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 or regulatory 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 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.
- Competent in communication, analysis and advice and taking ownership in your work and personal development.
- Fluent in English.
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? Then please submit your resume and letter of motivation to firstname.lastname@example.org or use our application form below.