IVD Regulatory Affairs Consultant
Europe, United States
Qserve is looking for a senior consultant with experience in regulatory affairs, quality assurance and performance evaluation in the IVD sector. We are a worldwide operating and fast-growing consulting & CRO firm in both the medical device and IVD sectors. Our Headquarter is in the Netherlands and we have local teams in UK, Germany, Belgium, China, and USA.
This is what you will be doing at Qserve:
As a Regulatory Affairs Consultant at our company, you provide specialist consulting services directly to customers. This could involve supporting customers transition from the IVDD to the IVDR or gain CE marking, FDA clearance or approval, or approvals in China for the first time.
As a consultant, no two days or customers are the same. You may be required to build a technical file to support CE marking or 510(k) submission or similar global approvals; however, it could also include strategy planning, in-depth reviews of performance evaluation or risk management data, creating and reviewing quality management system policies and procedures, performing gap analyses, internal or supplier audits to support and improve customers quality systems or perhaps delivering customer training.
You will be part of a team, no one is an expert on everything, so we support each other to play to our strengths so that we provide the best service to customers. This position is a great opportunity to apply your expertise and continue to build your experience. We know how important it is for our customers that we maintain our experience to be state of the art and we, therefore, hold monthly Qserve training days to ensure we provide consistent advice to customers as well as to continue to learn from each other.
And this is what you will bring:
- You have a technical or scientific degree (BSc, MSc or PhD) in biochemistry, chemistry, biomedical science, or similar.
- Minimal 7 to 10 years working experience specifically in IVDs through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA) in either manufacturing, R&D, quality or regulatory roles.
- You should have a good knowledge of IVD regulations specifically EU but US, Japan, Australia, would be an advantage.
- You should be comfortable reviewing performance evaluation data. For example, have you participated in design reviews within your company?
- You should have worked under an ISO 13485 quality system; audit experience is an advantage but not essential.
- You should be pragmatic, enjoy a mix of activities in technology, business processes, regulatory and quality.
- 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.
- Ability to manage moderately complex projects as a team leader; coaching and reviewing work of others.
- Have the ability to make clear decisions in simple to moderately complex issues using investigation and analysis skills.
- You should have strong organizational skills, be detailed oriented and capable of dealing with a variety of projects at the same time.
- Fluent in English.
- Working permit and driver’s license for Germany, the Netherlands or Belgium as appropriate.
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 creative in finding pragmatic solutions within projects for customers? Then please take a 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 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’ 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 clinical writer in the dynamic and innovating world of medical devices and in-vitro diagnostics? Then please submit your resume and letter of motivation to firstname.lastname@example.org or use the form below.
For more information about our company please visit our website (www.qservegroup.com) or contact our HR department at +31 20 78 82 630.
Enquiries from agencies are not appreciated.