Senior Consultant Medical Devices - Regulatory/Quality

Senior Consultant Medical Devices Regulatory Quality

Remote US

As a Qserve consultant, you serve a wide variety of clients in the medical device industry. You will be part of a team of medical device experts, working from across the world, dedicated to support our clients.  You might be involved in:

  • Developing the regulatory strategy to facilitate a quick market access and minimize the regulatory burden
  • writing or reviewing technical documentation
  • Fulfill ad interim RA positions
  • Perform compliance assessments of technical documentation against European MDR 2017/745 requirements
  • 510(k) or PMA submissions for US Market access
  • Lead or participate in MDR implementation projects
  • Perform GAP assessment and implement improvements in Quality management systems based on the ISO 13485 standard
  • Perform internal or mock 3rd party audits 

You work with a variety of devices, for manufacturers around the globe, either from home, or at the client’s site. Sometimes working alone, 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 Qserve team who can assist.

Does this sound like the next step in your career? Then Qserve, a fast growing organization offering employees a challenging job, with a lot of freedom to 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 bring

  • You have a technical or scientific degree (BSc, MSc or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology or similar.
  • At least 7 years of working experience in the field of medical devices through positions in industry, consultancy, FDA or Notified Body, in either quality, regulatory or clinical roles (e.g. Manager Regulatory Affairs & Quality Assurance).
  • Self-starter, able to pick up and run with projects and new tasks with little prescriptive direction
  • Knowledge of Medical Device Regulations (FDA, EU MDR, etc.)
  • Familiar with medical device quality assurance
  • Preferably auditing qualifications (ISO 13485/MDSAP)
  • Familiar with writing technical documentation and regulatory documents
  • Pragmatic, enjoying a mix of activities in regulatory affairs or quality assurance.
  • 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.
  • Familiar with Medical device quality assurance
  • 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.   
  • Preferably auditing qualifications (ISO 13485/MDR/MDSAP)
  • Fluent in English.

About Qserve

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 offers an international and dynamic work environment in which you can operate and develop in the innovative, fast-moving Medical Device and In Vitro Diagnostics sector. We offer flexibility and diversity in terms of clients, devices, 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. 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 creative in finding pragmatic solutions with projects? We would like to get in contact with you!

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 below. 

 
How can we help you? Contact us