Senior Consultant Regulatory Affairs /
Quality Assurance Medical Devices

Nanjing / Greater Shanghai / Beijing, China

Minimum 7 years working experience in Medical Devices /
knowledge of Medical Device Regulations and/or Quality Assurance

(Please find here the Chinese version of this vacancy).

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 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 Regulatory Affairs Consultant at 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 evaluations 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 on a specific expert area. On 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 In your expertise area, you will be responsible for writing blogs, whitepapers, news items, presentations or similar to promote knowledge base and the Qserve brand. 

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.
Minimum 7 to 10 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA), in either manufacturing, R&D, quality or regulatory roles.
Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) and/or quality assurance. Preferably European CE mark on high-risk non-active device and/or clinical experience.
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.
Fluent in English. 

“Global reach, practical approach, experienced team”

Interested?

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 careers@qservegroup.com or use our application form. For more information about our company, you can always visit our website or reach out to Stephanie Huang at Stephanie.huang@qservegroup.com or call at +86 133 05 15 29 92.

The function may be partly home-based; we expect our consultants to work at the client locations, from home and/ or from Nanjing office, depending on the need.

Enquiries from agencies are not appreciated.

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